The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,000
Administered SC
Administered SC
Percent Change from Baseline in Body Weight
Time frame: Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Time frame: Baseline, Week 80
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
Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 80
Percent Change from Baseline in Total Cholesterol
Time frame: Baseline, Week 80
Percent Change from Baseline in Triglycerides
Time frame: Baseline, Week 80
Change from Baseline in Hemoglobin (A1c) 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
Change from Baseline in Fasting Glucose
Time frame: Baseline, Week 80
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Pinnacle Research Group, LLC
Anniston, Alabama, United States
Cullman Clinical Trials
Cullman, Alabama, United States
Preferred Research Partners
Little Rock, Arkansas, United States
Core Healthcare Group
Cerritos, California, United States
Velocity Clinical Research, Westlake
Los Angeles, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Teradan Clinical Trials, LLC
Brandon, Florida, United States
...and 88 more locations
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
Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 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 GSA2 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 component.
Time frame: Baseline to Week 80
Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 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 GSA2 Subset
Time frame: Week 80