CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 783 enrolled
Drug / intervention
Tirzepatide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04660643
NCT04660643Phase 3Completed

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)

Eli Lilly and Company·interventional·Posted Dec 9, 2020·Updated May 22, 2024

In Brief

A Phase 3 clinical trial evaluating Tirzepatide and Placebo for Obesity and Overweight. Completed, enrolled 783 participants across 70 sites in 5 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Overweight
CountriesArgentina, Brazil, Puerto Rico, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 9, 2020
Enrollment StartMar 29, 2021
Primary CompletionApr 25, 2023
Study CompletionMay 18, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.6 years ago

Interventions

Tirzepatidedrug

Administered SC

Placeboother

Administered SC