ATTAIN-OSA

Active not recruitingPhase 3

A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight

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

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

600

estimated

Study population

Obesity / overweight, Sleep apnea

Key I/E criterion

•BMI ≥27

Primary endpoint

•AHI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06649045

Org study ID27226

Secondary IDJ5P-MC-GZ01Eli Lilly and Company

Secondary IDJ5P-MC-GZ02Eli Lilly and Company

Secondary IDJ5P-MC-GZRAEli Lilly and Company

Timeline

Milestones

Study first posted2024-10-18actual

Study start2024-10-22actual

Last update posted2025-09-29actual

Primary completion2026-11estimated (month precision)

Study completion2027-01estimated (month precision)

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Obesity / overweightSleep apnea

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Weight & body composition

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline to Week 52

Body weight, % change

percent change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change from Baseline in high-sensitivity C reactive protein (hsCRP) Concentration

Time frame:Baseline to Week 52

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

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

change from baseline, improvement

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Change from Baseline in Apnea-Hypopnea Index (AHI)

Time frame:Baseline to Week 52

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in AHI

Time frame:Baseline to Week 52

AHI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)

Time frame:Baseline to Week 52

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving ≥50% AHI Reduction

Time frame:Baseline to Week 52

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

Percent of Participants with AHI<5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10

Time frame:Baseline to Week 52

OSA responder

threshold achievement, improvement

componentsAHI, change, PGI, change

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.