A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

• Status: Recruiting
• Trial end date: 2023-07-17
• Target enrollment: 0
• Participant gender: All

Summary

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: LY3298176; Tirzepatide

Criteria

Inclusion Criteria:

• 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)

• Have a BMI of ≥27 kg/m²

• Are overweight or have obesity

• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

• Are at least 18 years of age and age of majority per local laws and regulations

Exclusion Criteria:

• Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM

• Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3

• Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment

• Have self-reported change in body weight >5kg within 3 months prior to screening

• Have had a history of chronic or acute pancreatitis

• Change in body weight greater than 5 kg within 3 months prior to starting study

• Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity

• Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

• History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years

• Any lifetime history of a suicide attempt