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NCT06649045 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Overweight or Obesity and OSA, sponsored by Eli Lilly and Company.

Active
Registry status
Phase 3
Development phase
600
Enrollment target
20
Study locations

NCT06649045: Active Phase 3 study of Overweight or Obesity and OSA, sponsored by Eli Lilly and Company.

NCT06649045 is a Phase 3 study of Overweight or Obesity and OSA that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 600 participants, below the 31,694-participant average among 32 other Overweight or Obesity trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06649045, a Phase 3 study of Overweight or Obesity and OSA, is active but no longer recruiting, sponsored by Eli Lilly and Company.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
600 participants
Enrollment target
20
Study locations

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.

Interventions

  • DRUG Placebo
  • DRUG Orforglipron

Study Locations (20)

Other

  • Centro de Investigaciones Metabólicas (CINME) - Buenos Aires
  • Centro Médico Viamonte - Buenos Aires
  • Consultorio de Investigación Clínica EMO SRL - Buenos Aires
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada - Buenos Aires
  • Centro Privado de Medicina Respiratoria - Paraná

California

  • Ark Clinical Research - Long Beach
  • Peninsula Research Associates - Rolling Hills Estates
  • Artemis Institute for Clinical Research - San Diego

Pennsylvania

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

Texas

  • FutureSearch Trials of Neurology - Austin
  • Prime Revival Research Institute, LLC - Flower Mound

Colorado

  • Care Access - Aurora - Aurora

Georgia

  • EBGS Clinical Research Center - Snellville

Idaho

  • Elite Clinical Trials - Blackfoot

Louisiana

  • Care Access - Shreveport - Shreveport

Trial Details

FieldValue
Enrollment Target 600 participants
Start Date 2024-10-22
Est. Completion 2027-01
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the registry record for NCT06649045 still lists

NCT06649045 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 31,694-participant average among 32 other Overweight or Obesity trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Overweight or Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06649045 names 20 study sites across 12 states, led by Other, California, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06649045 about?

NCT06649045 is a clinical study titled "A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight". 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...

What is the current status of trial NCT06649045?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 600 participants. The study started on 2024-10-22. Estimated completion is 2027-01.

What conditions does trial NCT06649045 study?

This clinical trial studies the following conditions: Overweight or Obesity, OSA.

What interventions are being tested in trial NCT06649045?

The interventions under investigation include: Placebo (DRUG), Orforglipron (DRUG).

Who is sponsoring clinical trial NCT06649045?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06649045 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Idaho, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Overweight or Obesity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06649045's enrollment target sits among peer trials

600 7th of 32 higher than 26 of 32 other Overweight or Obesity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Overweight or Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06649045, the US trial registry maintained by the National Library of Medicine. NCT06649045 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.