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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: OSA, Overweight or Obesity

In brief

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.

Key facts

Study ID

NCT06649045

Run by

Eli Lilly and Company

People needed

600

Starts

2024-10-22

Expected to finish

2027-01-01

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peninsula Research Associates — Rolling Hills Estates, California, United States
• Artemis Institute for Clinical Research — San Diego, California, United States
• Care Access - Aurora — Aurora, Colorado, United States
• EBGS Clinical Research Center — Snellville, Georgia, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Care Access - Shreveport — Shreveport, Louisiana, United States
• The Sleep Spot - Maimonides — Albuquerque, New Mexico, United States
• Accellacare - Wilmington — Wilmington, North Carolina, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) — Pittsburgh, Pennsylvania, United States
• Preferred Primary Care Physicians — Uniontown, Pennsylvania, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States
• Prime Revival Research Institute, LLC — Flower Mound, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Centro de Investigaciones Metabólicas (CINME) — Buenos Aires, Argentina
• Centro Médico Viamonte — Buenos Aires, Argentina
• Consultorio de Investigación Clínica EMO SRL — Buenos Aires, Argentina
• Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires, Argentina
• Centro Privado de Medicina Respiratoria — Paraná, Argentina
• Instituto Médico Río Cuarto — Río Cuarto, Argentina
• INECO Neurociencias Oroño — Rosario, Argentina
• Centro de Salud e Investigaciones Médicas — Santa Rosa, Argentina
• Núcleo de Pesquisa Clínica do Rio Grande do Sul — Porto Alegre, Brazil
• CPQuali Pesquisa Clínica — São Paulo, Brazil
• Ark Clinical Research — Long Beach, California, United States

Full record on ClinicalTrials.gov

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