A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight (SURMOUNT-2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity; Type 2 Diabetes

Treatments: Other: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04657003

I8F-MC-GPHL (Other Identifier)

17245

Details and patient eligibility

About

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

Enrollment: 938 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
• Have a BMI of ≥27 kg/m²
• Are overweight or have obesity
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
• Are at least 18 years of age and age of majority per local laws and regulations

Exclusion criteria

• Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
• Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values >270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
• Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
• Have self-reported change in body weight >5kg within 3 months prior to screening
• Have had a history of chronic or acute pancreatitis
• Change in body weight greater than 5 kg within 3 months prior to starting study
• Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
• Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
• Any lifetime history of a suicide attempt

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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938 participants in 3 patient groups, including a placebo group

10 milligrams (mg) Tirzepatide

Experimental group

Description:

10 mg Tirzepatide administered subcutaneously (SC) once weekly (QW)

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

15 mg Tirzepatide administered SC QW

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC QW

Treatment:

Other: Placebo