Continued Treatment With Tirzepatide for Maintenance of Weight Reduction in Adults With Obesity
Author:
Aronne Louis J.1, Sattar Naveed2, Horn Deborah B.3, Bays Harold E.4, Wharton Sean5, Lin Wen-Yuan6, Ahmad Nadia N.7, Zhang Shuyu7, Liao Ran7, Bunck Mathijs C.7, Jouravskaya Irina8, Murphy Madhumita A.7, Fretes José O9, Coronel Maria J9, Gutnisky Lucas L9, Frechtel Gustavo D9, Gelersztein Elizabeth9, Aizenberg Diego9, Maldonado Natacha9, Pereira Márcio9, Santos Queulla G9, Calil Salim Camila9, Canani Luis H9, Halpern Bruno9, Russo Luis AT9, Bodart Joselita9, Neto Danilo V9, Augusto Gustavo9, Leite Silmara9, Yang Yi-Ching9, Lin Wen-Yuan9, Huang Chien-Ning9, Huang Kuo-Chin9, Fitz-Patrick David9, Pau Cindy HT9, Toth Phillip D9, Freeman George H9, Gardner Donald F9, Wynne Alan G9, Loy Juan9, Horn Deborah B9, Mehra Purvi K9, Layle Stacey9, Bergthold James H9, de Souza Jose9, Nadar Venkatesh K9, Albizu Angulo Gustavo R9, Cohen Kenneth R9, Smith Timothy R9, Aronne Louis J9, Vaughn Michael9, Alcantara-Gonzalez Altagracia A9, Forman Seth B9, Agaiby John M9, Geller Steven A9, Fraser Neil J9, Jenders Robert A9, Barbel-Johnson Kim M9, Mayfield Ronald K9, Vance Carl D9, Prier Kevin T9, Murray Alexander V9, Lillestol Michael J9, Denham Douglas S9, Park Jean Y9, Klein Eric J9, Bays Harold E9, Philis-Tsimikas Athena9, Bressler Peter E9, Reed John CH9, Aslam Shamaila9, Rosenstock Julio9, Frias Juan P9, Klaff Leslie J9, Brazg Ronald9, Gomez-Cuellar Martha9, Connery Lisa9, Van Joanna T9, Selam Jean-Louis9, Kim John9, Blake Dwight9, Gabriel John9, Arora Samir9, McCartney Michael J9, Solano Royce K9, Brodie Steven K9, Nardandrea John P9,
Affiliation:
1. Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, New York 2. BHF Glasgow Cardiovascular Research Centre, School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, United Kingdom 3. University of Texas Center for Obesity Medicine and Metabolic Performance, Department of Surgery, University of Texas McGovern Medical School, Houston 4. Louisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky 5. McMaster University, and Wharton Weight Management Clinic, York University, Toronto, Ontario, Canada 6. Department of Family Medicine, China Medical University Hospital, Taichung, Taiwan 7. Eli Lilly and Company, Indianapolis, Indiana 8. Eli Lilly and Company, Moscow, Russia 9. for the SURMOUNT-4 Investigators
Abstract
ImportanceThe effect of continued treatment with tirzepatide on maintaining initial weight reduction is unknown.ObjectiveTo assess the effect of tirzepatide, with diet and physical activity, on the maintenance of weight reduction.Design, Setting, and ParticipantsThis phase 3, randomized withdrawal clinical trial conducted at 70 sites in 4 countries with a 36-week, open-label tirzepatide lead-in period followed by a 52-week, double-blind, placebo-controlled period included adults with a body mass index greater than or equal to 30 or greater than or equal to 27 and a weight-related complication, excluding diabetes.InterventionsParticipants (n = 783) enrolled in an open-label lead-in period received once-weekly subcutaneous maximum tolerated dose (10 or 15 mg) of tirzepatide for 36 weeks. At week 36, a total of 670 participants were randomized (1:1) to continue receiving tirzepatide (n = 335) or switch to placebo (n = 335) for 52 weeks.Main Outcomes and MeasuresThe primary end point was the mean percent change in weight from week 36 (randomization) to week 88. Key secondary end points included the proportion of participants at week 88 who maintained at least 80% of the weight loss during the lead-in period.ResultsParticipants (n = 670; mean age, 48 years; 473 [71%] women; mean weight, 107.3 kg) who completed the 36-week lead-in period experienced a mean weight reduction of 20.9%. The mean percent weight change from week 36 to week 88 was −5.5% with tirzepatide vs 14.0% with placebo (difference, −19.4% [95% CI, −21.2% to −17.7%]; P < .001). Overall, 300 participants (89.5%) receiving tirzepatide at 88 weeks maintained at least 80% of the weight loss during the lead-in period compared with 16.6% receiving placebo (P < .001). The overall mean weight reduction from week 0 to 88 was 25.3% for tirzepatide and 9.9% for placebo. The most common adverse events were mostly mild to moderate gastrointestinal events, which occurred more commonly with tirzepatide vs placebo.Conclusions and RelevanceIn participants with obesity or overweight, withdrawing tirzepatide led to substantial regain of lost weight, whereas continued treatment maintained and augmented initial weight reduction.Trial RegistrationClinicalTrials.gov Identifier: NCT04660643
Publisher
American Medical Association (AMA)
Cited by
108 articles.
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