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A Master Protocol for Orforglipron in Participants With Obstructive Sleep Apnea and Obesity or Overweight
NCT06649045 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06649045 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06649045?
The interventions under investigation include: Placebo (DRUG), Orforglipron (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06649045?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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