The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
2,300
Administered SC
Administered SC
Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Arizona Research Center
Phoenix, Arizona, United States
Medical Investigations
Little Rock, Arkansas, United States
Neuro-Pain Medical Center
Fresno, California, United States
Valley Research
Fresno, California, United States
Percent Change From Baseline in Body Weight
Time frame: Baseline, Week 80
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Time frame: Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset
Time frame: Baseline, Week 80
Percent Change from Baseline in Body Weight to
Time frame: Baseline, Week 104
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 80
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 80
Percent Change form Baseline in Fasting Insulin
Time frame: Baseline, Week 80
Change from Baseline in HbA1c
Time frame: Baseline, Week 80
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time frame: Baseline, Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
AUC is presented as a single average measure of AUC across the study duration.
Time frame: Baseline through Week 80
Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset
Time frame: Baseline, Week 80
Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset
Time frame: Baseline, Week 80
Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset
Time frame: Baseline, Week 80
Percent Change from Baseline in AHI for GSA1 Subset
Time frame: Baseline, Week 80
A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA1 Subset
A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.
Time frame: Baseline to Week 80
Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset
Time frame: Baseline to Week 80
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset
Time frame: Week 80
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Artemis Institute for Clinical Research
San Diego, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Teradan Clinical Trials, LLC
Brandon, Florida, United States
...and 124 more locations