A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

• Status: Completed
• Trial end date: 2020-10-28
• Target enrollment: 0
• Participant gender: All

Summary

The goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. The study will last approximately 47 weeks and may include about 15 visits.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Gastric Inhibitory Polypeptide; Tirzepatide

Criteria

Inclusion Criteria:

• Have been diagnosed with type 2 diabetes mellitus (T2DM).

• Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening.

• Have HbA1c between ≥7.0% and ≤9.5%.

• Be of stable weight (± 5%) for at least 3 months before screening.

• Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

Exclusion Criteria:

• Have type 1 diabetes mellitus.

• Have had chronic or acute pancreatitis any time prior to study entry.

• Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.

• Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss.

• Have an estimated glomerular filtration rate <30 mL/minute/1.73 m².

• Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months.

• Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2.

• Have been taking weight loss drugs, including over-the-counter medications during the last 3 months.