A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight (ATTAIN-OSA)

September 26, 2025 updated by: Eli Lilly and Company

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial

Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinical_inquiry_hub@lilly.com

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1120AAC
        • Centro Médico Viamonte
      • Buenos Aires, Argentina, C1056ABI
        • Centro de Investigaciones Metabólicas (CINME)
      • Buenos Aires, Argentina, C1405BUB
        • Consultorio de Investigacion Clinica EMO SRL
      • Buenos Aires, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Paraná, Argentina, 3100
        • Centro Privado de Medicina Respiratoria
      • Rosario, Argentina, 2000
        • INECO Neurociencias Orono
      • Río Cuarto, Argentina, X5800AEV
        • Instituto Medico Rio Cuarto
      • Santa Rosa, Argentina, L6300
        • Centro de Salud e Investigaciones Médicas
  • Brazil
      • Porto Alegre, Brazil, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas FMUSP
      • São Paulo, Brazil, 01236030
        • BR Trials - Ensaios Clinicos e Consultoria
  • China
      • Beijing, China, 100034
        • Peking University People's Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Chengdu, China, 610072
        • Sichuan Provincial People's Hospital
      • Harbin, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
      • Huzhou, China, 313000
        • Huzhou Central Hospital
      • Luoyang Shi, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Nanchang, China, 330006
        • Jiangxi Provincial People's Hospital
      • Ningbo, China, 315010
        • Ningbo First Hospital
      • Shanghai, China, 201200
        • Pudong New Area People's Hospital Shanghai
      • Shenzhen, China, 518020
        • ShenZhen People's Hospital
      • Wuxi, China, 214023
        • Wuxi People's Hospital
  • Czechia
      • Benešov, Czechia, 256 01
        • Nemocnice Rudolfa a Stefanie Benešov
      • Prague, Czechia, 14900
        • Milan Kvapil s.r.o., Diabetologicka ambulance
      • Prague, Czechia, 150 00
        • Praglandia s.r.o
  • Germany
      • Bamberg, Germany, 96049
        • CIMS Studienzentrum Bamberg
      • Berlin, Germany, 10117
        • Advanced Sleep Research
      • Essen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Essen, Germany, 45359
        • Unterfrintroper Hausarztzentrum Klinische Forschung
      • Hanover, Germany, 30449
        • Siteworks GmbH - Hannover
      • Karlsruhe, Germany, 76137
        • Siteworks - Karlsruhe
      • Münster, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster
      • Oldenburg, Germany, 23758
        • RED-Institut GmbH
  • Japan
      • Kitakyushu, Japan, 802-0052
        • Kirigaokatsuda Hospital
      • Osaka, Japan, 532-0003
        • Osaka Kaisei Hospital
      • Sakai, Japan, 593-8304
        • Sakai City Medical Center
      • Urasoe, Japan, 901-2132
        • Nakamura Clinic
      • Yokohama, Japan, 222-0033
        • RESM Respiratory and Sleep Medical Care Clinic
  • Mexico
      • Chihuahua City, Mexico, 31110
        • Enclifar Ensayos Clínicos Farmacológicos Sc
      • Guadalajara, Mexico, 44130
        • Diseno y Planeacion en Investigacion Medica
      • Guadalajara, Mexico, 44670
        • Private Practice - Dr. Arechavaleta Granell Maria del Rosario
      • Mexicali, Mexico, 21200
        • Centro de Investigacion en Artritis y Osteoporosis SC
      • Mexico City, Mexico, 03100
        • RM Pharma Specialists - Unidad Especializada en Datos
      • Mexico City, Mexico, 11650
        • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
      • Monterrey, Mexico, 64020
        • CEINV Salud
  • Taiwan
      • Chiayi City, Taiwan, 600
        • Chiayi Christian Hospital
      • Taichung, Taiwan, 404332
        • China Medical University Hospital
      • Tainan City, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taoyuan District, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
  • United States
    • California
      • Long Beach, California, United States, 90815
        • Ark Clinical Research
      • Rolling Hills Estates, California, United States, 90274
        • Peninsula Research Associates
      • San Diego, California, United States, 92103
        • Artemis Institute for Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Care Access - Aurora
    • Georgia
      • Snellville, Georgia, United States, 30078
        • EBGS Clinical Research Center
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Care Access - Shreveport
    • New Mexico
      • Albuquerque, New Mexico, United States, 87107
        • The Sleep Spot - Maimonides
    • North Carolina
      • Wilmington, North Carolina, United States, 28401
        • Accellacare - Wilmington
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Flower Mound, Texas, United States, 75028
        • Prime Revival Research Institute, LLC
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Orforglipron

Participants will receive orforglipron orally.

Study 1 GZ01: Participants who are unable or unwilling to use PAP

Study 2 GZ02: Participants who plan to continue PAP therapy
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Placebo Comparator: Placebo

Participants will receive placebo orally.

Study 1 GZ01: Participants who are unable or unwilling to use PAP

Study 2 GZ02: Participants who plan to continue PAP therapy
Drug: Placebo
Administered orally.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Apnea-Hypopnea Index (AHI)
Time Frame: Baseline to Week 52
Baseline to Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percent Change from Baseline in AHI
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-score
Time Frame: Baseline to Week 52
Baseline to Week 52
Percentage of Participants Achieving ≥50% AHI Reduction
Time Frame: Baseline to Week 52
Baseline to Week 52
Percent of Participants with AHI<5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10
Time Frame: Baseline to Week 52
Baseline to Week 52
Percent Change from Baseline in Body Weight
Time Frame: Baseline to Week 52
Baseline to Week 52
Change from Baseline in high-sensitivity C reactive protein (hsCRP) Concentration
Time Frame: Baseline to Week 52
Baseline to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27226
  • J5P-MC-GZRA (Other Identifier: Eli Lilly and Company)
  • J5P-MC-GZ01 (Other Identifier: Eli Lilly and Company)
  • J5P-MC-GZ02 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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