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

Part of paid clinical trials in Long Beach, California.

Sponsor
Eli Lilly and Company
Study ID
NCT06649045
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • OSA
  • Overweight or Obesity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orforglipron — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.

Study Details

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 Dates

Start date
Oct 22, 2024
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Orforglipron
    Participants will receive orforglipron orally. Study 1 GZ01: Participants who are unable or unwilling to use PAP Study 2 GZ02: Participants who plan to continue PAP therapy
  • Placebo Comparator: Placebo
    Participants will receive placebo orally. Study 1 GZ01: Participants who are unable or unwilling to use PAP Study 2 GZ02: Participants who plan to continue PAP therapy

Primary Outcome Measure

Change from Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: Baseline to Week 52 ]

Locations (15)

FacilityCityStateZIP
Ark Clinical ResearchLong BeachCalifornia90815
Peninsula Research AssociatesRolling Hills EstatesCalifornia90274
Artemis Institute for Clinical ResearchSan DiegoCalifornia92103
Care Access - AuroraAuroraColorado80012
EBGS Clinical Research CenterSnellvilleGeorgia30078
Elite Clinical TrialsBlackfootIdaho83221
Care Access - ShreveportShreveportLouisiana71105
The Sleep Spot - MaimonidesAlbuquerqueNew Mexico87107
Accellacare - WilmingtonWilmingtonNorth Carolina28401
CTI Clinical Research CenterCincinnatiOhio45212
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)PittsburghPennsylvania15236
Preferred Primary Care PhysiciansUniontownPennsylvania15401
FutureSearch Trials of NeurologyAustinTexas78731
Prime Revival Research Institute, LLCFlower MoundTexas75028
Northwest Clinical Research CenterBellevueWashington98007

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Ark Clinical Research· Long Beach, CAPeninsula Research Associates· Rolling Hills Estates, CAArtemis Institute for Clinical Research· San Diego, CACare Access - Aurora· Aurora, COEBGS Clinical Research Center· Snellville, GAElite Clinical Trials· Blackfoot, ID

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