A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes

• Status: Recruiting
• Trial end date: 2024-10-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Dulaglutide; Immunoglobulin Fc Fragments; Tirzepatide

Criteria

Inclusion Criteria:

• Have a diagnosis of type 2 diabetes

• Have confirmed atherosclerotic cardiovascular disease

• HbA1c ≥7.0% to ≤10.5%

• Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)

Exclusion Criteria:

• Have had a major cardiovascular event within the last 60 days

• Have type 1 diabetes mellitus

• Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months

• Are currently planning treatment for diabetic retinopathy and/or macular edema

• Currently planning a coronary, carotid, or peripheral artery revascularization

• Have a history of pancreatitis

• Have a history of ketoacidosis or hyperosmolar state/coma

• Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery

• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years

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

• Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement