Purpose

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.

Condition

Eligibility

Eligible Ages
Over 40 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 - Have a history of proliferative diabetic retinopathy; or diabetic maculopathy; or non-proliferative diabetic retinopathy that requires acute treatment - 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 plan to have during the course of the study, or chronically take drugs that directly affect gastrointestinal (GI) motility - 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)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide
Tirzepatide administered subcutaneously (SC) once a week.
  • Drug: Tirzepatide
    Administered SC
    Other names:
    • LY3298176
Active Comparator
Dulaglutide
Dulaglutide administered SC once a week.
  • Drug: Dulaglutide
    Administered SC
    Other names:
    • LY2189265

Recruiting Locations

University of Alabama at Birmingham Medical Center
Birmingham, Alabama 35294
Contact:
205-975-9564

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
Clinicaltrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.