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Trial · Interventional

CompletedPhase 3Registry data

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

Short name ATTAIN-OSA

NCTNCT06649045 (opens ClinicalTrials.gov in a new tab)Other id27226Other idJ5P-MC-GZRAOther idJ5P-MC-GZ01Other idJ5P-MC-GZ02
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
712 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
9 countries

United States, Argentina, Brazil, China, Czechia, Germany, Japan, Mexico, Taiwan

Start
22 Oct 2024
Primary completion
21 Jul 2026
Completion
30 Jul 2026
First posted
18 Oct 2024
Last update posted
14 Sept 2026
Conditions
OSA · Overweight or Obesity

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 3

    ATTAIN-OSA

    NCT06649045

    22 Oct 2024 to 30 Jul 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OrforglipronDrug
  • PlaceboDrug

Arms2

  • 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

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change from Baseline in Apnea-Hypopnea Index (AHI)

    Time frame · Baseline to Week 52

Secondary outcomes(7)

  1. Percent Change from Baseline in AHI

    Time frame · Baseline to Week 52

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

    Time frame · Baseline to Week 52

  3. 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

  4. Percentage of Participants Achieving ≥50% AHI Reduction

    Time frame · Baseline to Week 52

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

    Time frame · Baseline to Week 52

  6. Percent Change from Baseline in Body Weight

    Time frame · Baseline to Week 52

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

    Time frame · Baseline to Week 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

PubMed tag: none · 2026

Orforglipron for the treatment of moderate-to-severe obstructive sleep apnea in adults with obesity or overweight: Study design and baseline characteristics of ATTAIN-OSA, a phase 3 trial.

Malhotra et al. 2026Contemporary clinical trials communicationscited by 1

PMID 42383207PMC13316212DOI 10.1016/j.conctc.2026.101660PUB-42383207

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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