A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (SURMOUNT-4)

Lilly

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Tirzepatide; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04660643

I8F-MC-GPHN (Other Identifier)

17247

Details and patient eligibility

About

This was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).

Enrollment: 783 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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783 participants in 3 patient groups, including a placebo group

Tirzepatide (lead-in)

Experimental group

Description:

Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.

Treatment:

Drug: Tirzepatide

Tirzepatide MTD

Experimental group

Description:

Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants received weekly doses of placebo SC for 52 weeks.

Treatment:

Other: Placebo