Participants with type 2 diabetes who have obesity or are overweight

Phase 3

Completed

• Conditions: Health Condition 1: E116- 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

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-04-07
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 26

Inclusion Criteria

1. 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

1. 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