A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (SURMOUNT-3)

Lilly

Status and phase: Completed; Phase 3

Conditions: Overweight; Obesity

Treatments: Other: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04657016

I8F-MC-GPHM (Other Identifier)

17246

Details and patient eligibility

About

This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).

Enrollment: 579 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or 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

---

579 participants in 2 patient groups, including a placebo group

Tirzepatide

Experimental group

Description:

Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants received matching placebo SC once weekly (QW).

Treatment:

Other: Placebo