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NCT07226765·Phase 3·INTERVENTIONAL

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

Maridebart cafraglutideWeight lossRecruiting

Status

Recruiting

Phase

Phase 3

Enrollment

250

Locations

54

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are not on PAP therapy and are living with overweight or obesity.

Interventions

Treatment arms and agents.

DRUG

Maridebart cafraglutide

Participants will receive maridebart cafraglutide SC.

DRUG

Placebo

Participants will receive placebo SC.

Timeline

From registration to results.

  1. First posted

    Nov 10, 2025

  2. Study start

    Nov 25, 2025

  3. Primary completion

    Sep 29, 2027

  4. Study completion

    Sep 13, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jun 12, 2026

Outcomes

What the study measures.

Primary outcomes

Change in Apnea-hypopnea Index (AHI) from baseline at Week 52

Time frame · At Week 52

Secondary outcomes

Percent Change in AHI from baseline at Week 52

Time frame · At Week 52

Participants Achieving ≥ 50% AHI Reduction from baseline at Week 52

Time frame · At Week 52

Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at Week 52

Time frame · At Week 52

Percent Change in Body Weight from baseline at Week 52

Time frame · At Week 52

Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52

Time frame · At Week 52

Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52

Time frame · At Week 52

Change in Systolic Blood Pressure (SBP) from baseline at Week 48

Time frame · At Week 48

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52

Time frame · At Week 52

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
99 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization. * Body Mass Index (BMI) of 27 kg/m\^2 or more at the time of screening. * History of at least one unsuccessful attempt at weight loss through diet and exercise. * Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling/unable to use PAP, and do not plan to use PAP therapy during the study. Exclusion Criteria: * Individuals who have had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery. * Those with significant craniofacial abnormalities that may affect breathing at screening. * Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration. * Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study. * Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.

Study locations

54 registered sites.

Australia · Brazil · Canada · Czechia · France · Germany · Hungary · Japan · Poland · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.

Valley Clinical Trials

Northridge, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Teradan Clinical Trials

Brandon, Florida, United States

Destiny Research Center

Palmetto Bay, Florida, United States

Clinical Research Center Of Florida

Pompano Beach, Florida, United States

NeuroTrials Research

Atlanta, Georgia, United States

Basil Clinical

Laurelton, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Epic Medical Research - DeSoto

DeSoto, Texas, United States

Sleep Therapy & Research Center

San Antonio, Texas, United States

Northwest Clinical Research Center

Bellevue, Washington, United States

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia

Royal Brisbane and Womens Hospital

Herston, Queensland, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Nucleo de Pesquisa do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Pesquisa Clinica de Campinas - Ipecc

Campinas, São Paulo, Brazil

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp

São Paulo, São Paulo, Brazil

CaRe Clinic

Calgary, Alberta, Canada

Aggarwal and Associates Ltd

Brampton, Ontario, Canada

Wharton Medical Clinic

Hamilton, Ontario, Canada

Diex Recherche Trois Rivieres

Trois-Rivières, Quebec, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Maridebart cafraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsMaridebart cafraglutide trial dashboard →