Participants with type 2 diabetes who have obesity or are overweight
Phase 3
Completed
- Conditions
- Type 2 diabetes mellitus with other specified complications,
- Registration Number
- CTRI/2021/09/036105
- Lead Sponsor
- Eli Lilly and Company India Pvt Ltd
- Brief Summary
This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 900
Inclusion Criteria
- Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening.
- T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs) 2.
- Have a BMI of ≥27 kg/m² 3.
- Are overweight or have obesity 4.
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight 5.
- Are at least 18 years of age and age of majority per local laws and regulations.
Exclusion Criteria
- Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM 2.
- Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3 3.
- Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment 4.
- Have self-reported change in body weight >5kg within 3 months prior to screening 5.
- Have had a history of chronic or acute pancreatitis 6.
- Change in body weight greater than 5 kg within 3 months prior to starting study 7.
- Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity 8.
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) 9.
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years 10.
- Any lifetime history of a suicide attempt.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieve ≥5% Body Weight Reduction from Randomization Randomization, 72 Weeks | 72 Weeks Percent Change from Randomization in Body Weight Randomization, 72 Weeks | 72 Weeks
- Secondary Outcome Measures
Name Time Method 16.Change from Randomization in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL Lite-CT) Physical Function Composite Score Randomization, 72 Weeks 1. Percentage of Participants Who Achieve ≥10% Body Weight Reduction from Randomization 2.Percentage of Participants Who Achieve ≥15% Body Weight Reduction from Baseline Pharmacokinetics (PK): Steady State Area Under the Concentration Curve (AUC) of Tirzepatide Baseline through Week 72 1.Change from Randomization in Absolute Body Weight 2.Change from Randomization in Body Mass Index
Trial Locations
- Locations (3)
All India Institute of Medical Sciences (AIIMS)
🇮🇳Delhi, DELHI, India
ILS Hospital
🇮🇳Kolkata, WEST BENGAL, India
Life Care Hospital and research Centre
🇮🇳Bangalore, KARNATAKA, India
All India Institute of Medical Sciences (AIIMS)🇮🇳Delhi, DELHI, IndiaDr Rajesh KhadgawatPrincipal investigator918527289001rajeshkhadgawat@hotmail.com