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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
712
Administered orally.
Administered orally.
Ark Clinical Research
Long Beach, California, United States
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
Change from Baseline in Apnea-Hypopnea Index (AHI)
Time frame: Baseline to Week 52
Percent Change from Baseline in AHI
Time frame: Baseline to Week 52
Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)
Time frame: Baseline to Week 52
Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-score
Time frame: Baseline to Week 52
Percentage of Participants Achieving ≥50% AHI Reduction
Time frame: Baseline to Week 52
Percent of Participants with AHI<5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10
Time frame: Baseline to Week 52
Percent Change from Baseline in Body Weight
Time frame: Baseline to Week 52
Change from Baseline in high-sensitivity C reactive protein (hsCRP) Concentration
Time frame: Baseline to Week 52
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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
...and 56 more locations