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A Study of Tirzepatide (LY3298176) in Adult Participants in India With Either Type 2 Diabetes Mellitus or Obesity

Active Not RecruitingPhase 4

Sponsor: Eli Lilly and Company

Conditions: Diabetes Mellitus, Type 2, Obesity, Overweight

Interventions: Tirzepatide

Countries: India

The main purpose of this study is to measure the safety and efficacy of tirzepatide in adult participants in India who have type 2 diabetes or who have obesity or overweight without type 2 diabetes. Participation in the study will last about 46 weeks.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Participants with Type 2 Diabetes:

* Have had type 2 diabetes for at least one year
* Insulin naive
* Have HbA1c ≥7.5% and ≤10% at screening
* Have body mass index (BMI) ≥23 kilograms per square meter (kg/m2)

Participants with Obesity or Overweight without Type 2 Diabetes:

* Have a BMI

  * Greater than or equal to 30 kg/m2 OR
  * 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:

Participants with Type 2 Diabetes:

* Have type 1 diabetes
* Have had any of the following heart conditions within 6 months prior to screening:

  * heart attack
  * stroke
  * hospitalization due to heart failure
* Have New York Heart Association Functional Classification Class III or IV congestive heart failure (CHF)
* 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:

* Have type 1 diabetes or type 2 diabetes
* Have a self-reported change in body weight greater than 5 kilograms (kg) (11 pounds) within 3 months prior to screening
* Have a prior or planned surgical treatment for obesity
* Have had any of the following heart conditions within 6 months prior to screening:

  * heart attack
  * stroke
  * hospitalization due to heart failure
* Have New York Heart Association Functional Classification Class III or IV CHF
* Have taken any medications or alternative remedies for weight loss within 3 months prior to screening

Locations (21)

Ahmedabad, India
Ahmedabad, India
Ahmedabad, India
Ajmer, India
Allahābād, India
Bengaluru, India
Bhubaneswar, India
Chennai, India
Coimbatore, India
Guwahati, India
Hyderabad, India
Jaipur, India
Kanpur, India
Kanpur, India
Kolkata, India
Kozhikode, India
Mumbai, India
Nagpur, India
Pune, India
Raipur, India
Visakhapatnam, India