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

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Tirzepatide; Drug: Dulaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04255433

17073

I8F-MC-GPGN (Other Identifier)

2019-002735-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 13,299 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13,299 participants in 2 patient groups

Tirzepatide

Experimental group

Description:

Tirzepatide administered subcutaneously (SC) once a week.

Treatment:

Drug: Tirzepatide

Dulaglutide

Active Comparator group

Description:

Dulaglutide administered SC once a week.

Treatment:

Drug: Dulaglutide