EndometriosisPhase 2ELENANCT05560646
A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 to 49 With Moderate to Severe Endometriosis-related Pain
A Phase 2 study testing OG-6219 in people with Endometriosis, run by Organon and Co at 86 sites in 11 countries.
Trial summary
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- OG-6219
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 354 participants
- Where
- 86 sitesin 11 countries
- Study dates
- 25 Oct 2022to 28 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1).
- Surgically (laparoscopy or laparotomy) diagnosed with endometriosis
- Moderate to severe endometriosis-related pelvic pain
- Regular menstrual cycles
- Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation.
- Normal breast exam at V1. In participants of ≥40 years mammography or contrast-enhanced breast MRI performed within the last 12 months prior to Screening (V1) without clinically significant abnormal findings.
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- Agree not to participate in another interventional study while participating in the present study.
- Able and willing to adhere to study procedures, including
- agree to use 2 forms of non-hormonal contraception throughout the study
- Must be willing and able to provide signed informed consent before any study-related activities
- Has demonstrated compliance with ≥75% of eDiary entries
- Has a negative pregnancy test
Who cannot join
- Surgical history of hysterectomy and/or bilateral oophorectomy
- Chronic pelvic and/or non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy
- Undiagnosed (unexplained), abnormal vaginal bleeding not associated with endometriosis within the past 6 months before screening.
- Presence of high-risk human papillomavirus (HPV).
- Has an active sexually transmitted infection (STI) (eg, gonorrhea, chlamydia, or trichomonas).
- Intends to become pregnant or breast feed during study participation or has a known or suspected pregnancy.
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- History of malignancy (except for basal cell or squamous cell skin cancer) before signing informed consent.
- History of family history of hereditary abnormal hemoglobin or an enzyme deficiency that can result in methemoglobinemia.
- Has a medical condition associated with hemolytic anemia
- Known human immunodeficiency virus infection, and/or acute or active, recurrent/relapsing, or chronic infection (eg, hepatitis A, B, or C virus)
- Has a clinically significant abnormal ECG or QT interval prolongation
- Used any medication that is either a sensitive substrate, moderate, or strong inhibitor or inducer of CYP3A4 within 30 days or 10 half-lives (whichever is longer) prior to the planned first day of dosing.
Trial locations and contacts
86 sites in 11 countries.
86 sites in 11 countries
United States27 sites
Bosque Women's Care
Albuquerque, New Mexico, 87109
MediSense Inc
Atlanta, Georgia, 30363
John Hopkins University
Baltimore, Maryland, 21205
Central Research Associates LLC dba Flourish Research
Birmingham, Alabama, 35205
UAB Center for Women's Reproductive Health
Birmingham, Alabama, 35233
Chattanooga Medical Research, LLC
Chattanooga, Tennessee, 37404
University of Cincinnati
Cincinnati, Ohio, 45267-0502
Paramount Research Solutions
College Park, Georgia, 30349
Centricity Research Dublin
Dublin, Ohio, 43016
Cedar Health Research, LLC
Euless, Texas, 76040
Penn State Health Women's Health Clinic
Hershey, Pennsylvania, 17033
The Women's Hospital of Texas
Houston, Texas, 77024
Clinical Trial Network LLC
Houston, Texas, 77074
Olympia Clinical Trials
Los Angeles, California, 90036
Infinite Clinical Trials
Morrow, Georgia, 30260
Ochsner Health Center - Baptist McFarland Medical Plaza
New Orleans, Louisiana, 70115
Tidewater Clinical Research
Norfolk, Virginia, 23502
Yale Fertility Center
Orange, Connecticut, 06477
The Advanced Gynecologic Surgery Institute
Park Ridge, Illinois, 60068
Clinical Research of Philadelphia, LLC
Philadelphia, Pennsylvania, 19114
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Northeast Clinical Research of San Antonio
San Antonio, Texas, 78233
Physician Care Clinical Research, LLC
Sarasota, Florida, 34239
Seattle Women's: Health, Research, Gynecology
Seattle, Washington, 98105
Omni Fertility and Laser Institute
Shreveport, Louisiana, 71118
Palmetto Clinical Research
Summerville, South Carolina, 29485
University of South Florida
Tampa, Florida, 33606
Poland17 sites
Specjalistyczna Poradnia Ginekologiczna Janusz Tomaszewski Spółka Komandytowa
Bialystok, 15-224
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Bialystok, 15-267
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Katowice, 40-081
Clinical Medical Research Sp. z o.o.
Katowice, 40-156
NZOZ Medem
Katowice, 40-301
Centra Medyczne Medyceusz
Lodz, 91-053
Specjalistyczny Gabinet Ginekologiczno-Położniczy
Lublin, 20-064
Centrum Medyczne Chodzki HLK
Lublin, 20-093
KO-MED Centra Kliniczne Lublin II
Lublin, 20-362
ETYKA Osrodek Badan Klinicznych
Olsztyn, 10-117
Etg Siedlce
Siedlce, 08-110
Klinika Leczenia Niepłodności, Ginekologii i Położnictwa Bocian
Szczecin, 70-225
MICS Centrum Medyczne Torun
Torun, 87-100
Specjalistyczna Praktyka Lekar
Warsaw, 00-144
PRATIA S.A. MTZ Clinical Research Powered by Pratia
Warsaw, 02-172
WIM Panstwowy Instytut Badawczy Centralny Szpital Kliniczny MON
Warsaw, 04-141
Przychodnia Wielospecjalistyczna Sk-Medica Spółka Z O.O.
Wroclaw, Dolnoslask, 54-034
Bulgaria10 sites
Medical Center Repromed EOOD
Pleven, 5800
UMHAT "Sv. Georgi", EAD
Plovdiv, 4002
DCC " Ascendent" EAD
Sofia, 1202
SHATOD - Sofia District, EOOD
Sofia, 1233
MHAT for women's health - Nadezhda, OOD
Sofia, 1330
DCC "Alexandrovska", EOOD
Sofia, 1431
Medical Center Hera EOOD
Sofia, 1510
Group practice for specialized medical care in the field of obstetrics and gynecology - Gin Art OOD
Sofia, 1606
MHAT NiaMed OOD
Stara Zagora, 6000
Acibadem City Clinic MC Varna EOOD
Varna, 9002
Belgium5 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
AZ Jan Palfijn Gent
Ghent, 9000
Universitair Ziekenhuis Ghent
Ghent, 9000
Jessa Ziekenhuis Hospital
Hasselt, 3500
CHU de Tivoli
La Louvière, 7100
Czechia5 sites
Fakultni nemocnice Brno
Brno, 602 00
Fertimed s.r.o.
Olomouc, 77900
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Femina Sana s.r.o.
Prague, 130 00
Ustav pro peci o matku a dite
Prague, 147 10
Hungary5 sites
Clinexpert Kft.
Budapest, 1033
Semmelweis Egyetem
Budapest, 1082
Szent Anna Maganrendelo
Debrecen, 4024
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, 7400
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Nyíregyháza, 4400
Italy5 sites
Università di Cagliari-Presidio Policlinico Monserrato
Monserrato, 09042
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Roma, 168
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Seriate, Milano, 20122
University of Siena Policlinico
Siena, 53100
Centro Ricerche Cliniche di Verona s.r.l.
Verona, 37134
France4 sites
Hopital Saint Joseph Paris
Paris, Paris, 75674
Hôpital Cochin
Paris, 75014
Hopital Tenon
Paris, 75020
Hospital of Hautepierre
Strasbourg, 67200
Germany3 sites
Charité - Campus Benjamin Franklin
Berlin, 13353
Universitaetsklinikum Duesseldorf AoeR
Düsseldorf, North Rhine-Westphalia, 40225
Universitätsklinikum des Saarlandes
Homburg, D-66421
Latvia3 sites
Latvian Maritime Medical Centre
Riga, LV-1005
Vitols & Vitols, Ltd.
Riga, LV-1006
Dr. Vasaraudze's Private Clinic
Riga, LV-1011
Sweden2 sites
Karolinska University Hospital
Stockholm, 17176
Danderyd Sjukhus
Stockholm, 182 88
About this study
Official title: A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age With Moderate to Severe Endometriosis-related Pain
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.
Read the detailed description
This is a global multicenter, Phase 2a/b, randomized, double-blind, Placebo-controlled study to assess the efficacy, safety, and tolerability of 3 dose levels of OG-6219, in pre-menopausal women 18 to 49 years of age (inclusive), who have been surgically diagnosed with endometriosis with moderate to severe endometriosis-related pain. This study includes treatment lasting approximately 16 weeks in total and is followed by a Safety Follow-up visit.
Pre-menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened and randomly assigned to study treatment. A minimum subset of 10 participants per treatment group (including Placebo group) will be voluntarily enrolled for optional intensive PK sampling for the entire duration of the study.
- Conditions
- Endometriosis
- Being tested
- OG-6219, Placebo
- Keywords
- Endometriosis Related Pain (ERP), Endometriosis, Pre-menopausal women
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OG-6219Drug
OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles.
PlaceboDrug
Participants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| Group A: OG-6219 Dose 1 | Experimental | Group A: OG-6219 Dose 1 BID Receives: Drug: OG-6219 |
| Group B: OG-6219 Dose 2 | Experimental | Group B: OG-6219 Dose 2 BID Receives: Drug: OG-6219 |
| Group C: OG-6219 Dose 3 | Experimental | Group C: OG-6219 Dose 3 BID Receives: Drug: OG-6219 |
| Group D: Placebo | Placebo comparator | Group D: Placebo BID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea or NMPP, and dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean OPP score was derived by the pain score for the dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. Baseline cycle OPP score was defined as the average daily OPP during baseline cycle.
Measured: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. Percentages are rounded off to the hundredth decimal place.
Measured: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. The TEAEs leading to permanent discontinuation of study drug was identified by using the 'Action taken with study treatment' variable equal to 'Drug withdrawal' from the AE page of the electronic case report form. Percentages are rounded off to the hundredth decimal place.
Measured: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
Secondary outcomes (24)
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean dysmenorrhea score was calculated for each cycle as the total of daily dysmenorrhea scores reported during the cycle divided by the number of days during the cycle when a dysmenorrhea score was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
Measured: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Mean Non-Menstrual Pelvic Pain Score at Treatment Cycle 3
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean NMPP score was calculated for each cycle as the total of daily NMPP scores reported during the cycle divided by the number of days during the cycle when a NMPP score was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
Measured: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Mean Dyspareunia Score at Treatment Cycle 3
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean dyspareunia score was calculated for each cycle as the total of dyspareunia scores reported during each cycle divided by the number of days when participants engaged in any sexual activity that involved full vaginal penetration during each cycle (that is, the number of days during the baseline cycle when a dyspareunia score was reported). Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
Measured: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Mean Number of Rescue Medication Tablets Used for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3
Participants were asked daily whether they used the rescue medication in the past 24 hours to treat their ERP. If yes, the number of tablets was documented. The mean number of tablets of rescue medication for ERP was calculated for each cycle as the total number of tablets of rescue medication for ERP reported during the cycle, divided by the number of days during the cycle when a value was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
Measured: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Percentage of Days With Participants Used Rescue Medication for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3
Participants were asked daily whether they used the rescue medication in the past 24 hours to treat their ERP. If yes, the number of tablets was documented. The percentage of days participant had used rescue medication for ERP was calculated for each cycle as the total number of days participant had used any rescue medication for ERP, divided by the number of days during the cycle when a value was reported. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
Measured: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Start of Treatment Cycle 1 in Participants With Patient Global Impression of Severity (PGI-S) to Start of Treatment Cycle 2, End of Treatment Cycles 2 and 3
The PGI-S was a single item measuring the overall severity of pelvic pain over the past 7 days on a 4-point Likert-type scale (0=None, 1=Mild, 2=Moderate, 3=Severe), score ranged from 0 (none) and 3 (severe), where lower score indicated a better outcome. Treatment Cycle 1 was the period between the first day of menses associated with treatment start (Visit 4) to the day prior to the first day of next menses, regardless of number of days.
Measured: Start of Treatment Cycle 1 (Day 1) and start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Percentage of Participants With Any Improvement on the Patient Global Impression of Change (PGI-C) at Start of Treatment Cycle 2 and End of Treatment Cycles 2 and 3
The PGI-C was a single item measuring the change in pelvic pain since the start of the study drug on a 5-point scale (0=much better, 1=a little better, 2=no change, 3=a little worse, 4=much worse), score ranged from 0 (much better) and 4 (much worse), where lower score indicated a better outcome. Participants with any improvement on the PGI-C were defined as a PGI-C score of 0 or 1 (0=much better and 1=a little better). Treatment Cycle 2 was the period between the first day of menses associated with start of treatment Cycle 2 to the day prior to the first day of next menses, regardless of number of days.
Measured: Start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Endometriosis Health Profile-30 (EHP-30) Domains Score at Treatment Cycle 3
The EHP-30 was a validated disease specific patient-reported outcome instrument measuring the health-related quality of life of women with endometriosis on a 5-point Likert-type scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=always). The EHP-30 consisted of 30 items with following domains: pain (11 items), score ranged from 0 (never) to 44 (always); controls and powerlessness (6 items), score ranged from 0 (never) to 24 (always); emotional well-being (6 items), score ranged from 0 (never) to 24 (always); social support (4 items), score ranged from 0 (never) to 16 (always); and self-image (3 items), score ranged from 0 (never) to 12 (always). Each domain lower score indicated a better outcome. Total EHP-30 score ranged from 0 (never) and 120 (always), where lower score indicated a better outcome. Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
Measured: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in C-Telopeptide of Type I Collagen (CTX) and Procollagen Type I N-Terminal Propeptide (P1NP) at End of Treatment Cycle 3
Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing CTX level and bone formation was determined by assessing P1NP level. Screening (Visit 1) was defined as the last measurement before study drug administration.
Measured: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Bone-Specific Alkaline Phosphatase (BSAP) and Osteocalcin at End of Treatment Cycle 3
Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone formation was determined by assessing BSAP and osteocalcin level. Screening (Visit 1) was defined as the last measurement before study drug administration.
Measured: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in N-Telopeptide of Type I Collagen (NTX) at End of Treatment Cycle 3
Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing NTX level. Screening (Visit 1) was defined as the last measurement before study drug administration. nmol BCE/L= nanomoles of bone collagen equivalents per liter.
Measured: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b) at End of Treatment Cycle 3
Potential effects on bone was monitored by biomarkers of bone resorption and formation. Bone resorption was determined by assessing TRAP5b level. Screening (Visit 1) was defined as the last measurement before study drug administration.
Measured: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Number of Participants With Clinically Significant Laboratory Abnormalities
Blood samples were collected to determine the clinical laboratory abnormalities. The laboratory assessments included chemistry, hematology and urinalysis.
Measured: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
Mean Change From Baseline Cycle in Sum of Days on Period at Treatment Cycles 1, 2 and 3
Participants recorded the presence of bleeding or spotting daily in the eDiary. The daily questions to assess bleeding pattern in the eDiary were "1a: During the past 24 hours, did you have any vaginal bleeding or spotting? If the response is "Yes", then the next question is, "1b: During the past 24 hours, have you been on your period?". Baseline cycle started at the start of menses associated with Visit 3 and ended at the day before the start of menses associated with Visit 4, or the day of Visit 4, whichever comes first.
Measured: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Number of Participants With Clinically Significant Electrocardiogram (ECG) Parameters Abnormalities
Triplicate standard 12-lead ECGs was obtained after the participant was in supine position for at least 5 minutes. The ECG measurements was summarized by taking the average of the available assessments. Only clinically significant ECG abnormalities are reported.
Measured: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
Mean Change From Screening in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Blood samples were collected to determine the serum level of LH and FSH. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration.
Measured: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Estrone (E1) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Blood samples were collected to determine the serum level of E1. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration.
Measured: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Progesterone, Testosterone and Dehydroepiandrosterone (DHEA) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Blood samples were collected to determine the serum level of progesterone, testosterone and DHEA. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration.
Measured: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Free Testosterone and Estradiol (E2) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Blood samples were collected to determine the serum level of free testosterone and E2. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration.
Measured: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Dehydroepiandrosterone Sulfate (DHEAS) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Blood samples were collected to determine the serum level of DHEAS. The LH surge was determined with urine LH kit at home. Screening (Visit 1) was defined as the last measurement before study drug administration.
Measured: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Plasma Concentrations of OG-6219 and FOR-1011
Blood samples were collected to determine plasma concentration of OG-6219 and FOR-1011. The plasma concentration of OG-6219 and FOR-1011 was analyzed using an appropriate validated bioanalytical method.
Measured: Pre-witness dose and 1.5 hours postdose on start of Treatment Cycle 1 (Day 1), at 7 days after urine LH surge, and end of Treatment Cycle 2; Pre-witness dose on end of Treatment Cycle 3
Maximum Concentration (Cmax) of OG-6219 and FOR-1011
Blood samples were collected to determine Cmax of OG-6219 and FOR-1011. The Cmax of OG-6219 and FOR-1011 was calculated using non-compartmental method. NCA= Noncompartmental analysis.
Measured: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
Time Taken to Reach the Maximum Concentration (Tmax) of OG-6219 and FOR-1011
Blood samples were collected to determine tmax of OG-6219 and FOR-1011. The tmax of OG-6219 and FOR-1011 was calculated using non-compartmental method.
Measured: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of OG-6219 and FOR-1011
Blood samples were collected to determine AUCtau of OG-6219 and FOR-1011. The AUCtau of OG-6219 and FOR-1011 was calculated using non-compartmental method.
Measured: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start25 Oct 2022
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
- Investigators
- Clinical Lead Late-Stage Clinical Development, Study director, Organon and Co
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560646
- Sponsor's protocol ID
- OG-6219-P001
- Acronym
- ELENA
- Status last verified
- Mar 2026
- First submitted
- 20 Sep 2022
- Last updated
- 8 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arbelaez F, Yureneva J, Larsson P, Colaci D, Gordon K, Dupclay L, Wilk K. A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Efficacy and Safety of Linustedastat (OG-6219) in Women with Moderate to Severe Endometriosis-Related Pain. Int J Womens Health. 2026 Sep 9;18:622776. doi: 10.2147/IJWH.S622776. eCollection 2026.
PubMed 42733850
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age With Moderate to Severe Endometriosis-related Pain
- ClinicalTrials.gov ID
- NCT05560646
- Acronym / sponsor ID
- ELENA / OG-6219-P001
- Conditions
- Endometriosis
- Keywords
- Endometriosis Related Pain (ERP), Endometriosis, Pre-menopausal women
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Posted 8 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this global Phase 2 study is to determine the efficacy, safety, and tolerability of 3 dose levels of OG-6219 in pre-menopausal women between 18 and 49 years of age (inclusive), who have moderate to severe endometriosis-related pain.
Detailed description
This is a global multicenter, Phase 2a/b, randomized, double-blind, Placebo-controlled study to assess the efficacy, safety, and tolerability of 3 dose levels of OG-6219, in pre-menopausal women 18 to 49 years of age (inclusive), who have been surgically diagnosed with endometriosis with moderate to severe endometriosis-related pain. This study includes treatment lasting approximately 16 weeks in total and is followed by a Safety Follow-up visit.
Pre-menopausal females aged 18 to 49 years old (inclusive), who have been surgically diagnosed with endometriosis will be screened and randomly assigned to study treatment. A minimum subset of 10 participants per treatment group (including Placebo group) will be voluntarily enrolled for optional intensive PK sampling for the entire duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: OG-6219 Dose 1 | Experimental | Drug: OG-6219Group A: OG-6219 Dose 1 BID |
| Group B: OG-6219 Dose 2 | Experimental | Drug: OG-6219Group B: OG-6219 Dose 2 BID |
| Group C: OG-6219 Dose 3 | Experimental | Drug: OG-6219Group C: OG-6219 Dose 3 BID |
| Group D: Placebo | Placebo comparator | Drug: PlaceboGroup D: Placebo BID |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Pre-menopausal females of age 18 to 49 years old (inclusive) at the time of signing Informed Consent (V1).
- Surgically (laparoscopy or laparotomy) diagnosed with endometriosis
- Moderate to severe endometriosis-related pelvic pain
- Regular menstrual cycles
- Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation.
Key exclusion criteria (12 listed)
- Surgical history of hysterectomy and/or bilateral oophorectomy
- Chronic pelvic and/or non-pelvic pain not caused by endometriosis that requires chronic analgesic or other chronic therapy
- Undiagnosed (unexplained), abnormal vaginal bleeding not associated with endometriosis within the past 6 months before screening.
- Presence of high-risk human papillomavirus (HPV).
- Has an active sexually transmitted infection (STI) (eg, gonorrhea, chlamydia, or trichomonas).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OG-6219OG-6219 Dose 1, Dose 2, Dose 3 BID: Participants will receive (orally) OG-6219 tablets during treatment cycles. | Drug | Group A: OG-6219 Dose 1, Group B: OG-6219 Dose 2, Group C: OG-6219 Dose 3 |
| PlaceboParticipants will receive (orally) OG-6219 Placebo tablets BID during treatment cycles. | Drug | Group D: Placebo |
Primary outcome
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3
Time frame: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Participants completed eDiary items for severity of their pain over the last 24 hours on 11-point NRS for dysmenorrhea or NMPP, and dyspareunia. Each item of the NRS pain severity score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. The mean OPP score was derived by the pain score for the dysmenorrhea and NMPP items, and score ranged from 0 (no pain) to 10 (worst pain imaginable), where lower score indicated a better outcome. Baseline cycle OPP score was defined as the average daily OPP during baseline cycle.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. An SAE was defined as any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. Percentages are rounded off to the hundredth decimal place.
Percentage of Participants With Treatment-Emergent Adverse Events Leading to Study Treatment Discontinuation
Time frame: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
An AE was defined as any untoward medical occurrence in a clinical study participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as events that first occur or worsen (increase in severity) after the first dose of study drug, during the treatment period, and up to 14 days (inclusive) after the last dose of study drug administration. The TEAEs leading to permanent discontinuation of study drug was identified by using the 'Action taken with study treatment' variable equal to 'Drug withdrawal' from the AE page of the electronic case report form. Percentages are rounded off to the hundredth decimal place.
24 secondary outcomes
Change From Baseline Cycle in Mean Dysmenorrhea Score at Treatment Cycle 3
Time frame: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Mean Non-Menstrual Pelvic Pain Score at Treatment Cycle 3
Time frame: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Mean Dyspareunia Score at Treatment Cycle 3
Time frame: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Mean Number of Rescue Medication Tablets Used for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3
Time frame: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Percentage of Days With Participants Used Rescue Medication for Endometriosis-Related Pain at Treatment Cycles 1, 2 and 3
Time frame: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Start of Treatment Cycle 1 in Participants With Patient Global Impression of Severity (PGI-S) to Start of Treatment Cycle 2, End of Treatment Cycles 2 and 3
Time frame: Start of Treatment Cycle 1 (Day 1) and start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Percentage of Participants With Any Improvement on the Patient Global Impression of Change (PGI-C) at Start of Treatment Cycle 2 and End of Treatment Cycles 2 and 3
Time frame: Start of Treatment Cycle 2 (Day 33), end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Change From Baseline Cycle in Endometriosis Health Profile-30 (EHP-30) Domains Score at Treatment Cycle 3
Time frame: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in C-Telopeptide of Type I Collagen (CTX) and Procollagen Type I N-Terminal Propeptide (P1NP) at End of Treatment Cycle 3
Time frame: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Bone-Specific Alkaline Phosphatase (BSAP) and Osteocalcin at End of Treatment Cycle 3
Time frame: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in N-Telopeptide of Type I Collagen (NTX) at End of Treatment Cycle 3
Time frame: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Tartrate-Resistant Acid Phosphatase 5b (TRAP5b) at End of Treatment Cycle 3
Time frame: Screening visit (Day -84) and end of Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
Mean Change From Baseline Cycle in Sum of Days on Period at Treatment Cycles 1, 2 and 3
Time frame: Baseline Cycle (up to Day -28) and Treatment Cycles 1 (Day 32), 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Number of Participants With Clinically Significant Electrocardiogram (ECG) Parameters Abnormalities
Time frame: From the first dose administration of the study drug (Day 1) up to 14 days after the last dose of study drug administration, approximately 108 days
Mean Change From Screening in Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Time frame: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Estrone (E1) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Time frame: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Progesterone, Testosterone and Dehydroepiandrosterone (DHEA) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Time frame: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Free Testosterone and Estradiol (E2) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Time frame: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Mean Change From Screening in Dehydroepiandrosterone Sulfate (DHEAS) at 7 Days After Urine Luteinizing Hormone Surge and End of Treatment Cycles 2 and 3
Time frame: Screening visit (Day -84) and 7 days after urine LH surge, end of Treatment Cycles 2 (Day 64) and 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).
Plasma Concentrations of OG-6219 and FOR-1011
Time frame: Pre-witness dose and 1.5 hours postdose on start of Treatment Cycle 1 (Day 1), at 7 days after urine LH surge, and end of Treatment Cycle 2; Pre-witness dose on end of Treatment Cycle 3
Maximum Concentration (Cmax) of OG-6219 and FOR-1011
Time frame: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
Time Taken to Reach the Maximum Concentration (Tmax) of OG-6219 and FOR-1011
Time frame: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
Area Under the Plasma Concentration-Time Curve During a Dosing Interval (AUCtau) of OG-6219 and FOR-1011
Time frame: Pre-witness dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours postdose on start of Treatment Cycle 1 (Day 1) and at 7 days after urine LH surge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42733850Arbelaez F, Yureneva J, Larsson P, Colaci D, Gordon K, Dupclay L, Wilk K. A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Efficacy and Safety of Linustedastat (OG-6219) in Women with Moderate to Severe Endometriosis-Related Pain. Int J Womens Health. 2026 Sep 9;18:622776. doi: 10.2147/IJWH.S622776. eCollection 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Lead Late-Stage Clinical Development study director
Organon and Co
86 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OG-6219 in people with Endometriosis, run by Organon and Co at 86 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United States, Poland, Bulgaria, Belgium, Czechia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline Cycle in Mean Overall Pelvic Pain Score at Treatment Cycle 3 (time frame: Baseline Cycle (up to Day -28) and Treatment Cycle 3 (Day 95). Each cycle was referred to 1 menstrual cycle (approximately 21 to 32 days).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05560646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.