Obesity, Obstructive Sleep Apnea, Overweight, Type 2 Diabetes
Conditions
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.
Interventions
DRUGRetatrutide
Administered SC
DRUGPlacebo
Administered SC
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
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Body Mass Index (BMI) | Baseline, 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 Diastolic Blood Pressure (DBP) | Baseline, Week 80 | — |
| Percent Change from Baseline in Total Cholesterol | Baseline, Week 80 | — |
| Percent Change from Baseline in Triglycerides | Baseline, Week 80 | — |
| 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 Fasting Glucose | 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. |
| Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset | 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. |
| Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset | Baseline to Week 80 | — |
| Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset | Week 80 | — |
Countries
Argentina, Australia, Brazil, India, Mexico, Romania, Spain, 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