A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight (SURMOUNT-1)

Lilly

Status and phase: Active, not recruiting; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04184622

17244

I8F-MC-GPHK (Other Identifier)

Details and patient eligibility

About

This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Enrollment: 2,539 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
• History of at least one unsuccessful dietary effort to lose body weight

Exclusion criteria

• Diabetes mellitus
• 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
• History of pancreatitis
• 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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2,539 participants in 4 patient groups, including a placebo group

5 mg Tirzepatide

Experimental group

Description:

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

Treatment:

Drug: Tirzepatide

10 mg Tirzepatide

Experimental group

Description:

10 mg tirzepatide administered SC once a week.

Treatment:

Drug: Tirzepatide

15 mg Tirzepatide

Experimental group

Description:

15 mg tirzepatide administered SC once a week.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC once a week.

Treatment:

Drug: Placebo