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New daily pill could ease sleep apnea for those with excess weight

NCT ID NCT06649045

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This phase 3 trial tests whether a once-daily pill called orforglipron can improve sleep apnea in 600 adults with moderate-to-severe sleep apnea who are also obese or overweight. Participants are split into two groups: those who cannot or will not use a CPAP machine, and those who already use CPAP. The main goal is to see if the drug reduces breathing pauses during sleep.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

712 people

The number who actually took part.

Started

Oct 2024

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Master GZRA inclusion criteria * have AHI ≥15 on PSG as part of the trial at screening (V1). * have body mass index (BMI) ≥27 kg/m² Study 1 GZ01 inclusion criteria * Participants who are unable or unwilling to use PAP therapy. * Participants must not have used PAP for at least 4 weeks prior to screening. Study 2 GZ02 inclusion criteria * Participants who have been on PAP therapy for at least 3 consecutive months prior to study start and plan to continue PAP therapy during the study. Exclusion Criteria: Master GZRA exclusion criteria * Have Type 1 diabetes (T1D) or Type 2 diabetes (T2D), history of ketoacidosis, or hyperosmolar state/coma * Have HbA1c ≥6.5% (≥ 48 mmol/mol), as determined by the central laboratory at Visit 1. * Had any previous or planned upper airway surgery for sleep apnea or major ear, nose or throat surgery * Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration * Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia. * Active device treatment of OSA other than PAP therapy * Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator. * Have a self-reported change in body weight \>5 kg within 3 months prior to screening * Have a prior or planned surgical treatment for obesity (excluding liposuction, abdominoplasty or cryolipolysis if performed more than 1 year prior to screening) * Have a prior or planned endoscopic and/or present device-based therapy for obesity. * Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity. Study 2 GZ02 exclusion criteria * Have personal or job-related responsibilities, or in the opinion of the investigator have any situation that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the study. * Are unwilling to temporary discontinue PAP therapy for 7 days prior to PSG testing during the study.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder obstructive sleep apnea syndrome Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OSA Overweight or obesity

Contacts and locations

Locations

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401, United States

  • Advanced Sleep Research

    Berlin, 10117, Germany

  • Ark Clinical Research

    Long Beach, California, 90815, United States

  • Artemis Institute for Clinical Research

    San Diego, California, 92103, United States

  • BR Trials - Ensaios Clinicos e Consultoria

    São Paulo, 01236030, Brazil

  • CEINV Salud

    Monterrey, 64020, Mexico

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, 04266-010, Brazil

  • CIMS Studienzentrum Bamberg

    Bamberg, 96049, Germany

  • CPQuali Pesquisa Clínica

    São Paulo, 01228-000, Brazil

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Care Access - Aurora

    Aurora, Colorado, 80012, United States

  • Care Access - Shreveport

    Shreveport, Louisiana, 71105, United States

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, 11650, Mexico

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC, Argentina

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC, Argentina

  • Centro Privado de Medicina Respiratoria

    Paraná, 3100, Argentina

  • Centro de Investigacion en Artritis y Osteoporosis SC

    Mexicali, 21200, Mexico

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI, Argentina

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, L6300, Argentina

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333, Taiwan

  • Chiayi Christian Hospital

    Chiayi City, 600, Taiwan

  • China Medical University Hospital

    Taichung, 404332, Taiwan

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires, C1405BUB, Argentina

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, 44130, Mexico

  • EBGS Clinical Research Center

    Snellville, Georgia, 30078, United States

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221, United States

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua City, 31110, Mexico

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731, United States

  • Hospital das Clinicas FMUSP

    São Paulo, 05403-000, Brazil

  • Huzhou Central Hospital

    Huzhou, 313000, China

  • INECO Neurociencias Oroño

    Rosario, 2000, Argentina

  • InnoDiab Forschung Gmbh

    Essen, 45136, Germany

  • Institut für Diabetesforschung GmbH Münster

    Münster, 48145, Germany

  • Instituto Médico Río Cuarto

    Río Cuarto, X5800AEV, Argentina

  • Jiangxi Provincial People's Hospital

    Nanchang, 330006, China

  • Kirigaokatsuda Hospital

    Kitakyushu, 802-0052, Japan

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Prague, 14900, Czechia

  • Nakamura Clinic

    Urasoe, 901-2132, Japan

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • Nemocnice Rudolfa a Stefanie Benešov

    Benešov, 256 01, Czechia

  • Ningbo First Hospital

    Ningbo, 315010, China

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Núcleo de Pesquisa Clínica do Rio Grande do Sul

    Porto Alegre, 90430-001, Brazil

  • Osaka Kaisei Hospital

    Osaka, 532-0003, Japan

  • Peking University People's Hospital

    Beijing, 100034, China

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274, United States

  • Praglandia s.r.o

    Prague, 150 00, Czechia

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401, United States

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

    Pittsburgh, Pennsylvania, 15236, United States

  • Prime Revival Research Institute, LLC

    Flower Mound, Texas, 75028, United States

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, 44670, Mexico

  • Pudong New Area People's Hospital Shanghai

    Shanghai, 201200, China

  • RED-Institut GmbH

    Oldenburg, 23758, Germany

  • RESM Respiratory and Sleep Medical Care Clinic

    Yokohama, 222-0033, Japan

  • RM Pharma Specialists - Unidad Especializada en Datos

    Mexico City, 03100, Mexico

  • Sakai City Medical Center

    Sakai, 593-8304, Japan

  • ShenZhen People's Hospital

    Shenzhen, 518020, China

  • Sichuan Provincial People's Hospital

    Chengdu, 610072, China

  • Siteworks - Karlsruhe

    Karlsruhe, 76137, Germany

  • Siteworks GmbH - Hannover

    Hanover, 30449, Germany

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, 471003, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, 150001, China

  • The Sleep Spot - Maimonides

    Albuquerque, New Mexico, 87107, United States

  • Unterfrintroper Hausarztzentrum Klinische Forschung

    Essen, 45359, Germany

  • Wuxi People's Hospital

    Wuxi, 214023, China

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Other studies related to the condition(s) this trial covers.