Candidiasis, InvasivePhase 3MARIONCT05178862

A Phase 3, Randomized, Double-blind Study for Patients With Invasive Candidiasis Treated With IV Echinocandin Followed by Either Oral Ibrexafungerp or Oral Fluconazole

A Phase 3 study testing SCY-078, Fluconazole and Echinocandin in people with Candidiasis, Invasive and Candidemia, run by Scynexis, Inc. at 101 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This is a multicenter, randomized, double-blind study of two treatment regimens for invasive candidiasis including candidemia. Subjects will receive intravenous echinocandin followed by oral ibrexafungerp (SCY-078) vs intravenous echinocandin followed by oral fluconazole. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Candidiasis, Invasive, Candidemia
What is being tested?: SCY-078, Fluconazole and Echinocandin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 101 sitesin 13 countries
Study dates: 3 Aug 2022to 16 Dec 2025
Phase: Phase 3
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).

Who cannot join

Subject has any of the following forms of invasive candidiasis at Screening:
Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed),
Osteomyelitis,
Endocarditis or myocarditis,
Meningitis, endophthalmitis, or any central nervous system infection,
Chronic disseminated candidiasis,

Show all 16Show fewer

Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract,
Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens,
Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection,
Patients who failed a previous antifungal therapy for the same infection,
Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis.
Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).
Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.
o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.
Baseline QTcF ≥ 500 msec.

Trial locations and contacts

101 sites in 13 countries.

Country

City, postcode or hospital

101 sites in 13 countries

United States26 sites

University of Michigan Hospital
Ann Arbor, Michigan, 48109
Augusta University Medical Center
Augusta, Georgia, 30912
University of Maryland Medical Center
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Alabama at Birmingham School of Medicine
Birmingham, Alabama, 70121
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Colorado Anschutz Medical Campus
Denver, Colorado, 80291
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Houston Methodist Hospital
Houston, Texas, 77030
University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Ochsner Medical Center
New Orleans, Louisiana, 70121
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15260
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
UC Davis Medical Center
Sacramento, California, 95817
UCSF School of Medicine
San Francisco, California, 94143
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
LSU Health Sciences Center
Shreveport, Louisiana, 71103
Washington University School of Medicine
St Louis, Missouri, 63110
Banner University Medical Center-Tucson
Tucson, Arizona, 85719

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China21 sites

Xiangya Hospital, Central South University
Changsha, Hunan, 410008
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Yuzhong, 400042
The First Affiliated Hospital of Guangzhou Medical University
Guandong, Guangzhou, 510230
The First Affiliated Hospital of Jinan University
Guandong, Guangzhou, 510630
Nanfang Hospital of Southern Medical University
Guangdong, Guangzhou, 510420
The Third Affiliated Hospital Of Sun Yat-Sen University (ZSSY)
Guangdong, Guangzhou, 510630
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Hainan General Hospital
Haikou, Hainan, 572000
The first affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhejiang Provincal Hospital of Chinese Medicine
Hangzhou, Zhejiang, 310006
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang
Chinese Academy of Medical Sciences
Jinghai, Tianjin Municipality, 301617
The First Hospital of Kunming
Kunming, Yunnan, 650034
Lishui People's Hospital
Lishui, Zhejiang, 323000
Liuzhou People's Hospital
Liuzhou, Liuzhou, 530021
Qingyuan People's Hospital
Qingyuan, Guangdong, 511518
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Huashan Hospital, Institute of Antibiotics
Shanghai, Shanghai Municipality, 200040
Shanghai 10th People's Hospital
Shanghai, Shanghai Municipality, 200072
Tianjin Medical University General Hospital
Xiaobailou, Tianjin Municipality, 300052

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Spain9 sites

Hospital Clínic de Barcelona
Barcelona, Catalonia, 08036
Hospital del Mar Medical Research Institute (IMIM)
Barcelona, Catalonia
University Hospital Ramon y Cajal
Madrid, 28034
General University Hospital Gregorio Maranon
Madrid
University Hospital de La Princesa
Madrid
University Hospital Puerta de Hierro Majadahonda
Madrid
University Hospital Virgen Macarena
Seville, Andalusia
University and Polytechnic Hospital La Fe
Valencia
University Clinical Hospital of Valencia
Valencia

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South Africa7 sites

Lakeview Hospital
Benoni, Gauteng, 1500
Netcare Jakaranda Hospital
Pretoria, Gauteng, 0002
Zuid-Afrikaans Hospital
Pretoria, Gauteng, 0002
Life Groenkloof Hospital
Pretoria, Gauteng, 0181
University of Pretoria and Steve Biko Academic Hospital
Pretoria
Mediclinic Victoria
Tongaat, KwaZulu-Natal, 4400
FCRN Clinical Trials Centre
Vereeniging, Gauteng, 1935

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Germany6 sites

University Hospital Cologne
Cologne, 50937
Frankfurt University Clinic
Frankfurt, 60596
University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg
Univeristy Hospital Jena
Jena, Thuringia
Municipal Hospital Munich GMbH/Hospital Neuperlach
Munich
Helios Clinic Wuppertal
Wuppertal

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France5 sites

Victor Dupouy Hospital Center Argenteuil
Argenteuil, 95107
Nantes University Hospital Center
Nantes, 44093
Paris University Hospitals Center- Cochin Hospital
Paris
Saint-Louis Hospital
Paris
University Hospital Center of Poitiers
Poitiers

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Greece5 sites

General Hospital of Athens "Evangelismos", 1st Department of Critical Care
Athens
General Hospital of Athens "Evangelismos"
Athens
LAIKO General Hospital
Athens
University General Hospital "Attikon"
Athens
General Hospital of Thessaloniki "Ippokratio"
Thessaloniki

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South Korea5 sites

Keimyung University - Dongsan Medical Center
Daegu
CHA Bundang Medical Center, CHA University
Gyeonggi-do
Gangnam Severance Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Wonju Severance Christian Hospital
Wŏnju

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Israel4 sites

Lady Davis Carmel Medical Center, Infectious Diseases Unit
Haifa
Rambam Health Care Campus, Institute of Infectious Diseases
Haifa
The Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Chaim Sheba Medical Center
Tel Litwinsky

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Italy4 sites

IRCCS- University Hospital San Martino-IST
Genoa, Liguria, 16132
Big Metropolitan Hospital Niguarda Regional Health Authority
Milan, 20162
University Polyclinic Hospital of Modena
Modena, 41124
Central Friuli University Healthcare Company
Udine

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Belgium3 sites

Saint Luc University Hospital
Brussels
University Hospital Ghent
Ghent
University Hospitals Leuven, Campus Gasthuisberg
Leuven

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Bulgaria3 sites

University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of Surgery
Plovdiv
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery
Sofia
University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"
Stara Zagora

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Canada3 sites

McGill University Health Centre
Montreal, Quebec, H4A 3J1
Princess Margaret Hospital
Toronto, Ontario
University Health Network- Toronto General Hospital
Toronto, Ontario

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About this study

Official title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)

Conditions: Candidiasis, Invasive, Candidemia
Being tested: SCY-078, Fluconazole, Echinocandin
Medical subject headings: Candidiasis, Invasive, Candidemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCY-078Drug
Also called Ibrexafungerp
Oral ibrexafungerp (SCY-078) as step-down therapy.
FluconazoleDrug
Also called Diflucan
Oral fluconazole (SCY-078) as step-down therapy.
EchinocandinDrug
Also called Caspofungin, Micafungin, Anidulafungin
Intravenous echinocandin

Study groups in NCT05178862
Study group	Role	What they receive
IV echinocandin followed by oral ibrexafungerp (SCY-078)	Experimental	Not described Receives: Drug: SCY-078; Drug: Echinocandin
IV echinocandin followed by oral fluconazole	Active comparator	Not described Receives: Drug: Fluconazole; Drug: Echinocandin

What is being measured

The primary outcome is the main question the study is designed to answer.

All-cause Mortality
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Measured: Day 30
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Measured: Up to 6 weeks

Secondary outcomes (1)

Global Response at Day 14
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee
Measured: Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 202216 Dec 2025

First posted5 Jan 2022
Study start3 Aug 2022
Primary completion7 Nov 2025
Study completion16 Dec 2025

Why it stopped: Strategic decision not related to safety or efficacy concerns for Ibrexafungerp.

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.
Other trials for Candidiasis, InvasiveStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05178862
Sponsor's protocol ID: SCY-078-302
Other IDs: MSG-20
Acronym: MARIO
Status last verified: Jul 2026
First submitted: 16 Dec 2021
Last updated: 10 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children
Invasive Candidiasis
RecruitingObservational study
Invasive Candidiasis in Critical Care
Invasive Candidiasis

All Candidiasis, Invasive trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Prospective, Randomized, Double-blind Study of Two Treatment Regimens for Candidemia and/or Invasive Candidiasis: Intravenous Echinocandin Followed by Oral Ibrexafungerp Versus Intravenous Echinocandin Followed by Oral Fluconazole (MARIO)
ClinicalTrials.gov ID: NCT05178862
Acronym / sponsor ID: MARIO / SCY-078-302
Conditions: Candidiasis, Invasive, Candidemia
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Strategic decision not related to safety or efficacy concerns for Ibrexafungerp.
Enrolment: 68 participants (actual)
Lead sponsor: Scynexis, Inc.Industry (pharma, biotech, devices)
Study start: 3 Aug 2022 (actual)
Primary completion: 7 Nov 2025 (actual)
Study completion: 16 Dec 2025 (actual)
First posted: 5 Jan 2022 (actual)
Results: Posted 10 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IV echinocandin followed by oral ibrexafungerp (SCY-078)	Experimental	Drug: SCY-078, Drug: Echinocandin
IV echinocandin followed by oral fluconazole	Active comparator	Drug: Fluconazole, Drug: Echinocandin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed.
Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever [on one occasion > 38°C], hypotension, or local signs of inflammation).

Key exclusion criteria (16 listed)

Subject has any of the following forms of invasive candidiasis at Screening:
Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 10-fold the upper limit of normal (ULN).
Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score > 9).
Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin.
o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible.

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
SCY-078Also: IbrexafungerpOral ibrexafungerp (SCY-078) as step-down therapy.	Drug	IV echinocandin followed by oral ibrexafungerp (SCY-078)
FluconazoleAlso: DiflucanOral fluconazole (SCY-078) as step-down therapy.	Drug	IV echinocandin followed by oral fluconazole
EchinocandinAlso: Caspofungin, Micafungin, AnidulafunginIntravenous echinocandin	Drug	IV echinocandin followed by oral fluconazole, IV echinocandin followed by oral ibrexafungerp (SCY-078)

Primary outcome

All-cause Mortality
Time frame: Day 30
The number and percentage of subjects in each treatment group who are alive and deceased in the ITT population.
Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)
Time frame: Up to 6 weeks
The percentage of subjects with Successful Global Response, as determined by the Data Review Committee

1 secondary outcome

Global Response at Day 14
Time frame: Day 14

Results and safety

Results posted to the registry on 10 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)	36	18
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy	32	17

Primary outcome: All-cause Mortality

Time frame: Day 30. Count of participants. Unit: Participants

Measure	IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) n = 36	IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy n = 32
Alive	28	28
Deceased	4	3
Not Known	4	1

Population analysed: 5 cases Not Known withdrew from the study prior to Day 30

Primary outcome: Global Response at End of Treatment (EU European Medicines Agency [EMA] Only)

Time frame: Up to 6 weeks. Count of participants. Unit: Participants

Measure	IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078) n = 0	IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy n = 0
Value	0	0

Population analysed: Study was terminated and data review committee was canceled. The data required to populate this table is not available due to the cancelation of the DRC. The data will not be available or reported in the future.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: For all randomized participants Adverse Events were collected and evaluated from the time the informed consent was signed through end of treatment. After end of treatment and up to the 6-week follow-up new adverse events were collected only if deemed related to the study drug, if it was a serious adverse event, or if it was related to a fungal infection. The period of time that Adverse Event data was collected for each participant was approximately 12 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IV Echinocandin Followed by Oral Ibrexafungerp (SCY-078)	20 of 36 (55.6%)	27 of 36 (75%)	4 of 36
IV Echinocandin Followed by Oral Fluconazole or Best Available Therapy	20 of 32 (62.5%)	28 of 32 (87.5%)	3 of 32

Limitations and caveats (from the sponsor): As of December 2025, the study has been discontinued. Enrollment target of 220 participants was not reached. All participants on study treatment at the time of study discontinuation were permitted to complete the study. The decision to terminate the MARIO study wass not related to safety or efficacy concerns for ibrexafungerp.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Candidiasis, Invasive

RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children
Invasive Candidiasis
RecruitingObservational study
Invasive Candidiasis in Critical Care
Invasive Candidiasis

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.

David Angulo, MD study director

Scynexis, Inc.

101 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCY-078, Fluconazole and Echinocandin in people with Candidiasis, Invasive and Candidemia, run by Scynexis, Inc. at 101 sites in 13 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 2 inclusion and 16 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: stopped early, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States, China, Spain, South Africa, Germany and 8 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. 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?

Yes. Results are posted in the registry (first posted 10 Aug 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?

All-cause Mortality (time frame: Day 30). The study lists 2 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 NCT05178862.

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 10 Aug 2026.