ObesityPhase 3KaiNETIC-1NCT07284875
Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
A Phase 3 study testing Ribupatide in people with Obesity and Overweight, run by Kailera at 110 sites in 10 countries.
Trial summary
The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Ribupatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,530 participants
- Where
- 110 sitesin 10 countries
- Study dates
- 18 Dec 2025to Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of the following:
- hypertension,
- dyslipidemia,
- obstructive sleep apnea, or
- cardiovascular (CV) disease.
- History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.
Who cannot join
- Current diagnosis or history of diabetes mellitus.
- Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to: tricyclic antidepressants, atypical antipsychotics, mood stabilizers, or phentermine.
- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
- Uncontrolled hypertension or unstable cardiovascular disease.
- History of chronic or acute pancreatitis.
Show all 11Show fewer
- Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.
- Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
110 sites in 10 countries.
110 sites in 10 countries
United States24 sites
Kailera Clinical Site
Amarillo, Texas, 79124
Kailera Clinical Site
Anniston, Alabama, 36207
Kailera Clinical Site
Aurora, Colorado, 80012
Kailera Clinical Site
Bellaire, Texas, 77401
Kailera Clinical Site
Birmingham, Alabama, 35294
Kailera Clinical Site
Bridgeport, Connecticut, 06606
Kailera Clinical Site
Chattanooga, Tennessee, 37405
Kailera Clinical Site
Chickasha, Oklahoma, 73018
Kailera Clinical Site
Columbia, Maryland, 21045
Kailera Clinical Site
Cullman, Alabama, 35055
Kailera Clinical Site
Danville, Virginia, 24541
Kailera Clinical Site
DeSoto, Texas, 75115
Kailera Clinical Site
Escondido, California, 92025
Kailera Clinical Site
Jupiter, Florida, 33458
Kailera Clinical Site
Las Vegas, Nevada, 89119
Kailera Clinical Site
Lilburn, Georgia, 30047
Kailera Clinical Site
Mauldin, South Carolina, 29662
Kailera Clinical Site
Morehead City, North Carolina, 28557
Kailera Clinical Site
Rochester, New York, 14609
Kailera Clinical Site
Salt Lake City, Utah, 84124
Kailera Clinical Site
Springfield, Illinois, 62072
Kailera Clinical Site
Sun City, Arizona, 85351
Kailera Clinical Site
Toluca Lake, California, 91602
Kailera Clinical Site
Tomball, Texas, 77375
Argentina13 sites
Kailera Clinical Site #1
Buenos Aires, Buenos Aires F.D., 1056
Kailera Clinical Site #2
Buenos Aires, Buenos Aires F.D., 1056
Kailera Clinical Site
Buenos Aires, Buenos Aires F.D., 1060
Kailera Clinical Site
Buenos Aires, Buenos Aires F.D., 1120
Kailera Clinical Site
CABA, 1061
Kailera Clinical Site
Córdoba, 5000
Kailera Clinical Site
Godoy Cruz, Mendoza Province, 5501
Kailera Clinical Site
La Plata, Buenos Aires, 1900
Kailera Clinical Site #1
Rosario, Santa Fe Province, 2000
Kailera Clinical Site #2
Rosario, Santa Fe Province, 2000
Kailera Clinical Site #3
Rosario, Santa Fe Province, 2000
Kailera Clinical Site #1
San Nicolás de los Arroyos, Buenos Aires, 2900
Kailera Clinical Site #2
San Nicolás de los Arroyos, Buenos Aires, 2900
Bulgaria11 sites
Kailera Clinical Site
Kyustendil, Kyustendil Province, 2500
Kailera Clinical Site
Pazardzhik, 4400
Kailera Clinical Site
Plovdiv, 4000
Kailera Clinical Site
Plovdiv, 4020
Kailera Clinical Site #1
Sofia, 1431
Kailera Clinical Site #2
Sofia, 1431
Kailera Clinical Site #3
Sofia, 1431
Kailera Clinical Site
Sofia, 1510
Kailera Clinical Site
Sofia, 1527
Kailera Clinical Site
Varna, 9020
Kailera Clinical Site
Yambol, 8600
Czechia11 sites
Kailera Clinical Site
Bohnice, Prague, 18100
Kailera Clinical Site
Brandýs nad Labem, Central Bohemia, 25001
Kailera Clinical Site
Brno, South Moravian, 61500
Kailera Clinical Site
Hodonín, 69501
Kailera Clinical Site
Krnov, Moravian-Silesian Region, 79401
Kailera Clinical Site
Náchod, Hradec Králové Region, 54701
Kailera Clinical Site
Olomouc, 77900
Kailera Clinical Site
Prague, Prague, 12808
Kailera Clinical Site
Prague, Prague, 14059
Kailera Clinical Site
Prague, 15000
Kailera Clinical Site
Uherské Hradiště, 68601
United Kingdom11 sites
Kailera Clinical Site
Bradford, West Yorkshire, BD9 6RJ
Kailera Clinical Site
Hounslow, TW4 7NJ
Kailera Clinical Site
Hull, East Yorkshire, HU3 2JZ
Kailera Clinical Site
Leicester, Leicestershire, LE5 4PW
Kailera Clinical Site
London, EC1M 6BQ
Kailera Clinical Site
Manchester, M13 9WL
Kailera Clinical Site
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Kailera Clinical Site
Nottingham, Nottinghamshire, NG7 2QW
Kailera Clinical Site
Soham, Cambridgeshire, CB7 5JD
Kailera Clinical Site
Stevenage, Hertfordshire, SG1 4AB
Kailera Clinical Site
Torpoint, Cornwall, PL11 2TB
Germany10 sites
Kailera Clinical Site
Cologne, North Rhine-Westphalia, 51069
Kailera Clinical Site
Dresden, Saxony, 01069
Kailera Clinical Site
Essen, North Rhine-Westphalia, 45355
Kailera Clinical Site
Falkensee, Brandenburg, 14612
Kailera Clinical Site
Hamburg, 22415
Kailera Clinical Site
Hamburg, 22607
Kailera Clinical Site
Leipzig, Saxony, 04107
Kailera Clinical Site
Oldenburg in Holstein, Schleswig-Holstein, 23758
Kailera Clinical Site
Schwerin, 19055
Kailera Clinical Site
Tübingen, Baden-Wurttemberg, 72076
Australia9 sites
Kailera Clinical Site
Charlestown, New South Wales, 2290
Kailera Clinical Site
Heidelberg Heights, Victoria, 3081
Kailera Clinical Site
Melbourne, Victoria, 3025
Kailera Clinical Site
Norwood, South Australia, 5067
Kailera Clinical Site
Sippy Downs, Queensland, 4556
Kailera Clinical Site
Sydney, New South Wales, 2019
Kailera Clinical Site
Sydney, New South Wales, 2100
Kailera Clinical Site
Sydney, New South Wales, 2228
Kailera Clinical Site
Wollongong, New South Wales, 2500
Spain9 sites
Kailera Clinical Site
Barcelona, Catalonia, 08035
Kailera Clinical Site
Barcelona, 08023
Kailera Clinical Site
Castilleja de la Cuesta, Sevilla, 41950
Kailera Clinical Site
Ferrol, A Coruna, 15402
Kailera Clinical Site
Madrid, 28003
Kailera Clinical Site
Oviedo, Principality of Asturias, 33011
Kailera Clinical Site
Seville, Andalusia, 41010
Kailera Clinical Site
Valencia, 46014
Kailera Clinical Site
Villamartín, Cadiz, 11650
Poland7 sites
Kailera Clinical Site
Krakow, Lesser Poland Voivodeship, 30-363
Kailera Clinical Site
Poznan, Greater Poland Voivodeship, 60-589
Kailera Clinical Site
Siedlce, Masovian Voivodeship, 08-110
Kailera Clinical Site
Skierniewice, 96-100
Kailera Clinical Site
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Kailera Clinical Site
Warsaw, Masovian Voivodeship, 00-872
Kailera Clinical Site
Zamość, 22-400
New Zealand5 sites
Kailera Clinical Site
Auckland, 0610
Kailera Clinical Site
Grafton, Auckland, 1010
Kailera Clinical Site
Hamilton, Waikato Region, 3200
Kailera Clinical Site
Nelson, 7011
Kailera Clinical Site
Silverdale, Auckland, 0932
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
- Conditions
- Obesity, Overweight
- Being tested
- Ribupatide, Placebo
- Keywords
- Overweight, Obesity, Ribupatide, KAI-9531, Glucagon-like Peptide-1, GLP-1, Glucose-dependent Insulinotropic Peptide, GIP
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibupatideDrug
Also called KAI-9531
SC Injection
PlaceboDrug
SC Injection
| Study group | Role | What they receive |
|---|---|---|
| Ribupatide: Dose 1 | Experimental | Participants will receive Dose 1 of ribupatide once weekly. Receives: Drug: Ribupatide |
| Ribupatide: Dose 2 | Experimental | Participants will receive Dose 2 of ribupatide once weekly. Receives: Drug: Ribupatide |
| Ribupatide: Dose 3 | Experimental | Participants will receive Dose 3 of ribupatide once weekly. Receives: Drug: Ribupatide |
| Ribupatide: Dose 4 | Experimental | Participants will receive Dose 4 of ribupatide once weekly. Receives: Drug: Ribupatide |
| Placebo | Placebo comparator | Participants will receive placebo matched to ribupatide once weekly. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Measured: Baseline, Week 76
Secondary outcomes (30)
Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Measured: Baseline, Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Measured: Baseline, Week 76
Change From Baseline in Waist Circumference
Measured: Baseline, Week 76
Change From Baseline in Absolute Body Weight
Measured: Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Measured: Baseline, Week 76
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Measured: Baseline, Week 76
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
Measured: Baseline, Week 76
Percentage of Participants with ≥30% Reduction in Body Weight
Measured: Baseline, Week 76
Change From Baseline in BMI
Measured: Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline, Week 76
Percent Change From Baseline in Total Cholesterol
Measured: Baseline, Week 76
Percent Change From Baseline in Low-density Lipoprotein (LDL)-cholesterol
Measured: Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
Measured: Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Measured: Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Measured: Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Measured: Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Measured: Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Measured: Up to Week 80
Plasma Concentrations of Ribupatide
Measured: Up to Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start18 Dec 2025
- Primary completionFeb 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kailera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Kailera Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284875
- Sponsor's protocol ID
- K9531-3103
- Other IDs
- 2025-523486-17-00, 2025
- Acronym
- KaiNETIC-1
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
- ClinicalTrials.gov ID
- NCT07284875
- Acronym / sponsor ID
- KaiNETIC-1 / K9531-3103
- Conditions
- Obesity, Overweight
- Keywords
- Overweight, Obesity, Ribupatide, KAI-9531, Glucagon-like Peptide-1, GLP-1, Glucose-dependent Insulinotropic Peptide, GIP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,530 participants (actual)
- Lead sponsor
- KaileraIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ribupatide: Dose 1 | Experimental | Drug: RibupatideParticipants will receive Dose 1 of ribupatide once weekly. |
| Ribupatide: Dose 2 | Experimental | Drug: RibupatideParticipants will receive Dose 2 of ribupatide once weekly. |
| Ribupatide: Dose 3 | Experimental | Drug: RibupatideParticipants will receive Dose 3 of ribupatide once weekly. |
| Ribupatide: Dose 4 | Experimental | Drug: RibupatideParticipants will receive Dose 4 of ribupatide once weekly. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to ribupatide once weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of the following:
- History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.
Key exclusion criteria (11 listed)
- Current diagnosis or history of diabetes mellitus.
- Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to: tricyclic antidepressants, atypical antipsychotics, mood stabilizers, or phentermine.
- Unstable weight defined as self-reported change in body weight exceeding 5% within 3 months prior to Screening.
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
- Uncontrolled hypertension or unstable cardiovascular disease.
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 |
|---|---|---|
| RibupatideAlso: KAI-9531SC Injection | Drug | Ribupatide: Dose 1, Ribupatide: Dose 2, Ribupatide: Dose 3, Ribupatide: Dose 4 |
| PlaceboSC Injection | Drug | Placebo |
Primary outcome
Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame: Baseline, Week 76
30 secondary outcomes
Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame: Baseline, Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Time frame: Baseline, Week 76
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 76
Change From Baseline in Absolute Body Weight
Time frame: Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time frame: Baseline, Week 76
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time frame: Baseline, Week 76
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 76
Percentage of Participants with ≥30% Reduction in Body Weight
Time frame: Baseline, Week 76
Change From Baseline in BMI
Time frame: Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 76
Percent Change From Baseline in Total Cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Low-density Lipoprotein (LDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
Time frame: Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Time frame: Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Time frame: Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Time frame: Up to Week 80
Plasma Concentrations of Ribupatide
Time frame: Up to Week 76
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- 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.
Medical Director study director
Kailera Therapeutics, Inc.
110 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ribupatide in people with Obesity and Overweight, run by Kailera at 110 sites in 10 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 6 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 110 sites in United States, Argentina, Bulgaria, Czechia, United Kingdom and 5 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 (time frame: Baseline, Week 76). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.