A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
- Conditions
- Obstructive Sleep ApneaOverweightObesityType 2 Diabetes
- Interventions
- Drug: Placebo
- Registration Number
- NCT05929079
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)
- Have Type 2 Diabetes (T2D)
- Are on stable treatment for T2D for at least 90 days
- Have a history of at least one unsuccessful dietary effort to lose body weight.
GSA2 Inclusion Criteria
- Previously diagnosed with OSA
- Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)
- For participants not on positive airway pressure (PAP) therapy: unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening.
- If on PAP therapy, have been on PAP therapy for at least 3 consecutive months prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.
- Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days.
- Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
- Have a prior or planned surgical treatment for obesity.
- Have Type 1 diabetes
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis
GSA2 Exclusion Criteria
- Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant, amphetamine) less than 3 months prior to screening.
- Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 months prior to screening.
- Use a dental appliance or other device to treat OSA other than PAP therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Retatrutide Dose 3 Retatrutide Participants will receive retatrutide SC. Retatrutide Dose 2 Retatrutide Participants will receive retatrutide SC. Retatrutide Dose 1 Retatrutide Participants will receive retatrutide subcutaneously (SC). Placebo Placebo Participants will receive placebo.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 80 Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset Baseline, Week 80
- Secondary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin (A1c) HbA1c % Baseline, Week 80 Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score Baseline, Week 80 Change from Baseline in Diastolic Blood Pressure (DBP) Baseline, Week 80 Change from Baseline in Body Mass Index (BMI) Baseline, Week 80 Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) Baseline through Week 80 AUC is presented as a single average measure of AUC across the study duration.
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset Week 80 Percent Change from Baseline in Total Cholesterol Baseline, Week 80 Percent Change from Baseline in Triglycerides Baseline, Week 80 Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset Baseline, Week 80 Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset Baseline to Week 80 Change from Baseline in Waist Circumference Baseline, Week 80 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 80 Change from Baseline in Fasting Glucose 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 Baseline to Week 80 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.
Trial Locations
- Locations (97)
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
Scroll for more (87 remaining)Pinnacle Research Group, LLC🇺🇸Anniston, Alabama, United States