OSA, Overweight or Obesity
Conditions
Brief 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.
Interventions
DRUGOrforglipron
Administered orally.
DRUGPlacebo
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
Master GZRA
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Apnea-Hypopnea Index (AHI) | Baseline to Week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in AHI | Baseline to Week 52 |
| Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour) | Baseline to Week 52 |
| Change from Baseline in Patient-Reported Outcome Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a T-score | Baseline to Week 52 |
| Percentage of Participants Achieving ≥50% AHI Reduction | Baseline to Week 52 |
| Percent of Participants with AHI<5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 | Baseline to Week 52 |
| Percent Change from Baseline in Body Weight | Baseline to Week 52 |
| Change from Baseline in high-sensitivity C reactive protein (hsCRP) Concentration | Baseline to Week 52 |
Countries
Argentina, Brazil, China, Czechia, Germany, Japan, Mexico, Taiwan, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed