A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone (SURPASS-1)

Lilly

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03954834

I8F-MC-GPGK (Other Identifier)

17000

Details and patient eligibility

About

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.

Enrollment: 478 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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478 participants in 4 patient groups, including a placebo group

5 mg Tirzepatide

Experimental group

Description:

Participants received 5 milligrams (mg) of tirzepatide as subcutaneous injection once a week.

Treatment:

Drug: Tirzepatide

10 mg Tirzepatide

Experimental group

Description:

Participants received 10mg of tirzepatide as subcutaneous injection once a week.

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

Participants received 15mg of tirzepatide as subcutaneous injection once a week.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants received placebo as subcutaneous injection once a week.

Treatment:

Drug: Placebo