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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-IN-GPIZ | Other Identifier | Eli Lilly and Company |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide subcutaneously (SC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration | A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Week 46 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with ≥5% Body Weight Reduction | Week 46 | |
| Percentage of Participants with Hemoglobin A1c (HbA1c) <7.0% in Participants with Type 2 Diabetes | Week 46 | |
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Inclusion Criteria:
Participants with Type 2 Diabetes:
Participants with Obesity or Overweight without Type 2 Diabetes:
Have a BMI
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:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| B. J. Medical College & Civil Hospital | Recruiting | Ahmedabad | 380 016 | India |
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Change from Baseline in Waist Circumference in Participants with Obesity or Overweight |
| Baseline, Week 46 |
| V.S. General Hospital | Not yet recruiting | Ahmedabad | 380006 | India |
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| Gujarat Endocrine Center | Recruiting | Ahmedabad | 380052 | India |
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| Jawahar Lal Nehru Medical College | Not yet recruiting | Ajmer | 305001 | India |
|
| Motilal Nehru Medical College Hospital | Recruiting | Allahābād | 211002 | India |
|
| Lifecare Hospital and Research Centre | Recruiting | Bengaluru | 560092 | India |
|
| AIIMS, Bhubaneshwar | Not yet recruiting | Bhubaneswar | 751019 | India |
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| Sri Ramachandra MedicaL College & Research Institute | Recruiting | Chennai | 600116 | India |
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| Kovai Diabetes Speciality Center and Hospital | Recruiting | Coimbatore | 641009 | India |
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| Apollo Excelcare Hospital | Recruiting | Guwahati | 781033 | India |
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| Osmania Medical College & Hospital | Recruiting | Hyderabad | 500012 | India |
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| Eternal Heart Care Center and Research Institute | Recruiting | Jaipur | 302017 | India |
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| K care Hospital | Recruiting | Kanpur | 208001 | India |
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| Brij Medical Centre Private Limited | Not yet recruiting | Kanpur | 208020 | India |
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| ILS Hospitals | Recruiting | Kolkata | 700064 | India |
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| Government Medical College, Kozhikode | Recruiting | Kozhikode | 673008 | India |
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| Wockhardt Hospitals | Not yet recruiting | Mumbai | 400011 | India |
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| Shri Krishna Hrudayalaya & Critical Care Centre | Recruiting | Nagpur | 440012 | India |
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| Sahyadri Super Speciality Hospital | Recruiting | Pune | 411004 | India |
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| All India Institute of Medical Sciences | Not yet recruiting | Raipur | 492099 | India |
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| King George Hospital, Andhra Medical College | Not yet recruiting | Visakhapatnam | 530002 | India |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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