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

NCT06649045 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-09-29

No results posted yet for this study

Summary

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.

Conditions

  • OSA
  • Overweight or Obesity

Interventions

DRUG

Orforglipron

Administered orally.

DRUG

Placebo

Administered orally.

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-22
Primary Completion
2026-11-30
Completion
2027-01-31
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06649045 on ClinicalTrials.gov