Health Condition 1: E669- Obesity, unspecified Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Tirzepatide: Participants will receive tirzepatide subcutaneously (SC)
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Eli Lilly and Company (India) Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Participants with Type 2 Diabetes: 1. Have had type 2 diabetes for at least one year 2. Insulin naive 3. Have HbA1c more than or equal to 7.5% and less than or equal to 10% at screening 4. Have body mass index (BMI) more than or equal to 23 kilograms per square meter (kg/m2) Participants with Obesity or Overweight without Type 2 Diabetes: 1. Have a BMI 2. Greater than or equal to 30 kg/m2 OR 3. Greater than or equal to 27 kg/m2 AND previously diagnosed with at least one of the following weight-related comorbidities: high blood pressure, lipid disorder, obstructive sleep apnea, heart disease
Exclusion criteria
Exclusion criteria: Participants with Type 2 Diabetes: 1. Have type 1 diabetes 2. Have had any of the following heart conditions within 6 months prior to screening: a) heart attack, b) stroke, c) hospitalization due to heart failure 3. Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF) 4. Have type 2 diabetes along with morbid obesity and being considered for bariatric surgery or any other procedure intended for weight loss Participants with Obesity or Overweight without Type 2 Diabetes: 1. Have type 1 diabetes or type 2 diabetes 2. Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening 3. Have a prior or planned surgical treatment for obesity 4. Have had any of the following heart conditions within 6 months prior to screening: a) heart attack, b) stroke, c) hospitalization due to heart failure 5. Have New York Heart Association Functional Classification Class III or IV CHF 6. Have taken any medications or alternative remedies for weight loss within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug AdministrationTimepoint: Baseline through Week 46 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of Participants with more than or equal to 5% Body Weight Reduction 2. Percentage of Participants with Hemoglobin A1c (HbA1c) less than 7.0% in Participants with Type 2 Diabetes 3. Change from Baseline in Waist Circumference in Participants with Obesity or OverweightTimepoint: 1. Week 46 2. Week 46 3. Baseline, Week 46 | — |
Countries
India
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company India Pvt. Ltd
Outcome results
None listed