A Study of LY3437943 in Participants with Type 2 Diabetes Mellitus who have Obesity or Overweight
Phase 3
Recruiting
- Conditions
- Health Condition 1: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2023/10/058324
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m²)
2. Have Type 2 Diabetes (T2D)
3. Are on stable treatment for T2D for at least 90 days
4. Have a history of at least one unsuccessful dietary effort to lose body weight
Exclusion Criteria
1. Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90 days
2. Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening
3. Have a prior or planned surgical treatment for obesity
4. Have Type 1 diabetes.
5. Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
6. Have had pancreatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body WeightTimepoint: Baseline, Week 80
- Secondary Outcome Measures
Name Time Method 1. Change from Baseline in Body Mass Index (BMI) <br/ ><br>2. Change from Baseline in Waist Circumference <br/ ><br>3. Change from Baseline in Systolic Blood Pressure <br/ ><br>4. Change from Baseline in Diastolic Blood Pressure <br/ ><br>5. Change from Baseline in Total Cholesterol <br/ ><br>6. Change from Baseline in Triglycerides <br/ ><br>7. Change from Baseline in Hemoglobin A1c (HbA1c) <br/ ><br>8. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score <br/ ><br>9. Change from Baseline in fasting glucose <br/ ><br>Timepoint: Baseline, Week 80;Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)Timepoint: Baseline through Week 80