NCT04660643

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

Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for Maintenance of Weight Loss in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-4)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 783 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	Tirzepatide	Administered SC
OTHER	Placebo	Administered SC

Timeline

• Start date: 2021-03-29
• Primary completion: 2023-04-25
• Completion: 2023-05-18
• First posted: 2020-12-09
• Last updated: 2024-05-22
• Results posted: 2024-05-22

Locations

70 sites across 5 countries: United States, Argentina, Brazil, Puerto Rico, Taiwan

Regulatory

• FDA-regulated drug study