A Study of LY3437943 in Obese or Overweight Patients
Phase 3
- Conditions
- Health Condition 1: E66- Overweight and obesity
- Registration Number
- CTRI/2023/11/059873
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Have body mass index (BMI) =30.0 kilograms per square meter (kg/m²), or =27.0 kg/m² with at least one of the following: hypertension, dyslipidemia
obstructive sleep apnea, or cardiovascular disease
2. History of at least one unsuccessful dietary effort to reduce 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 diabetes mellitus.
5. Have 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 (SBP) <br/ ><br>4. Percent Change form Baseline in Fasting Insulin <br/ ><br>5. Change from Baseline in HbA1c <br/ ><br>6. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain ScoreTimepoint: Baseline, Week 80;Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)Timepoint: Baseline through Week 80