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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-10-22 |
| Est. Completion | 2027-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06649045
The ClinicalTrials.gov registry entry for NCT06649045 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 31,694-participant average among 32 other Overweight or Obesity trials with a reported enrollment target (98% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Related
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