A Phase 4, Open-Label, Single-Arm, 46-Week Study to Investigate the Safety and Efficacy With Tirzepatide in Adult Indian Participants With Either Type 2 Diabetes or Obesity
Status: Recruiting
Location: See all (21) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
∙ 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
Locations
Other Locations
India
B. J. Medical College & Civil Hospital
RECRUITING
Ahmedabad
Gujarat Endocrine Center
RECRUITING
Ahmedabad
V.S. General Hospital
NOT_YET_RECRUITING
Ahmedabad
Jawahar Lal Nehru Medical College
NOT_YET_RECRUITING
Ajmer
Motilal Nehru Medical College Hospital
RECRUITING
Allahābād
Lifecare Hospital and Research Centre
RECRUITING
Bengaluru
AIIMS, Bhubaneshwar
NOT_YET_RECRUITING
Bhubaneswar
Sri Ramachandra MedicaL College & Research Institute
RECRUITING
Chennai
Kovai Diabetes Speciality Center and Hospital
RECRUITING
Coimbatore
Apollo Excelcare Hospital
RECRUITING
Guwahati
Osmania Medical College & Hospital
RECRUITING
Hyderabad
Eternal Heart Care Center and Research Institute
RECRUITING
Jaipur
Brij Medical Centre Private Limited
NOT_YET_RECRUITING
Kanpur
K care Hospital
RECRUITING
Kanpur
ILS Hospitals
RECRUITING
Kolkata
Government Medical College, Kozhikode
RECRUITING
Kozhikode
Wockhardt Hospitals
NOT_YET_RECRUITING
Mumbai
Shri Krishna Hrudayalaya & Critical Care Centre
RECRUITING
Nagpur
Sahyadri Super Speciality Hospital
RECRUITING
Pune
All India Institute of Medical Sciences
NOT_YET_RECRUITING
Raipur
King George Hospital, Andhra Medical College
NOT_YET_RECRUITING
Visakhapatnam
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date:2026-02-27
Estimated Completion Date:2027-10
Participants
Target number of participants:344
Treatments
Experimental: Tirzepatide
Participants will receive tirzepatide subcutaneously (SC)