Participants without Type 2 Diabetes who are Overweight.
- Conditions
- Other specified diabetes mellituswith other specified complications,
- Registration Number
- CTRI/2020/04/024660
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks (14 visits). Participants with prediabetes will continue in the extension for another 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2400
Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease History of at least one unsuccessful dietary effort to lose body weight.
Diabetes mellitus Change in body weight greater than 5 kg within 3 months prior to starting study Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity History of pancreatitis Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years Any lifetime history of a suicide attempt.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 72 | Week 72 Percentage of Participants who Achieve ≥5% Body Weight Reduction Baseline, Week 72 | Week 72
- Secondary Outcome Measures
Name Time Method Change from Baseline in Body Weight Baseline, Week 20 Percent Change from Baseline in Body Weight Baseline, Week 176 Percentage of Participants who Achieve ≥10% Body Weight Reduction Percentage of Participants who Achieve ≥15% Body Weight Reduction Percentage of Participants who Achieve ≥5% Body Weight Reduction Week 176 Change from Baseline in Waist Circumference Change from Baseline in Body Mass Index (BMI) Time to Onset of Type 2 Diabetes Baseline through Week 176 Change from Baseline in Hemoglobin A1c (HbA1c) Change from Baseline in Triglycerides Change from Baseline in Diastolic Blood Pressure Change from Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide Baseline through Week 72
Trial Locations
- Locations (10)
All India Institute of Medical Sciences (AIIMS)
🇮🇳Delhi, DELHI, India
AMRITA Institute of Medical Sciences and Research Centre
🇮🇳Kollam, KERALA, India
Care Hospitals
🇮🇳Hyderabad, TELANGANA, India
CHL-Hospitals [Unit of Convenient Hospitals Ltd]
🇮🇳Indore, MADHYA PRADESH, India
Deenanath Mangeshkar Hospital & Research Center
🇮🇳Pune, MAHARASHTRA, India
Fortis Hospital
🇮🇳Delhi, DELHI, India
Grant Government Medical College & Sir J. J. Group of Hospitals
🇮🇳Mumbai, MAHARASHTRA, India
Gujarat Endocrine Centre
🇮🇳Ahmadabad, GUJARAT, India
ILS Hospitals
🇮🇳Kolkata, WEST BENGAL, India
Topiwala National Medical College & BYL Nair Hospital
🇮🇳Mumbai, MAHARASHTRA, India
All India Institute of Medical Sciences (AIIMS)🇮🇳Delhi, DELHI, IndiaDr Naval Kishore VikramPrincipal investigator9810007331navalvikram@gmail.com