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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)
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Cahaba Research
Pelham, Alabama, United States
Scripps Memorial Hospital La Jolla
La Jolla, California, United States
National Research Institute - Wilshire
Los Angeles, California, United States
National Research Institute
Panorama City, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
University Clinical Investigators, Inc.
Tustin, California, United States
New West Physicians Clinical Research
Golden, Colorado, United States
Optumcare Colorado Springs - Monument
Monument, Colorado, United States
Care Partners Clinical Research
Jacksonville, Florida, United States
South Florida Clinical Research Institute
Margate, Florida, United States
Start Date
March 29, 2021
Primary Completion Date
April 25, 2023
Completion Date
May 18, 2023
Last Updated
May 22, 2024
783
ACTUAL participants
Tirzepatide
DRUG
Placebo
OTHER
Lead Sponsor
Eli Lilly and Company
NCT01143454
NCT07472881
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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