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Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial.
Nat Med. 2023 Nov; 29(11):2909-2918.NMed

Abstract

The effects of tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, on weight reduction after successful intensive lifestyle intervention are unknown. This double-blind, placebo-controlled trial randomized (1:1) adults with body mass index ≥30 or ≥27 kg/m[2] and at least one obesity-related complication (excluding diabetes), who achieved ≥5.0% weight reduction after a 12-week intensive lifestyle intervention, to tirzepatide maximum tolerated dose (10 or 15 mg) or placebo once weekly for 72 weeks (n = 579). The treatment regimen estimand assessed effects regardless of treatment adherence in the intention-to-treat population. The coprimary endpoint of additional mean per cent weight change from randomization to week 72 was met with changes of -18.4% (standard error (s.e.) 0.7) with tirzepatide and 2.5% (s.e. 1.0) with placebo (estimated treatment difference -20.8 percentage points (95% confidence interval (CI) -23.2%, -18.5%; P < 0.001). The coprimary endpoint of the percentage of participants achieving additional weight reduction ≥5% was met with 87.5% (s.e. 2.2) with tirzepatide and 16.5% (s.e. 3.0) with placebo achieving this threshold (odds ratio 34.6%; 95% CI 19.2%, 62.6%; P < 0.001). The most common adverse events with tirzepatide were gastrointestinal, with most being mild to moderate in severity. Tirzepatide provided substantial additional reduction in body weight in participants who had achieved ≥5.0% weight reduction with intensive lifestyle intervention. ClinicalTrials.gov registration: NCT04657016 .

Links

Authors+Show Affiliations

Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA. wadden@pennmedicine.upenn.edu.

Johns Hopkins School of Nursing, Baltimore, MD, USA.

Division of Endocrinology and Metabolism, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.

Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.

Department of Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC, USA.

Department of Medicine, Division of Diabetes, Endocrinology & Metabolism, Department of Pediatrics, Department of Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA. Vanderbilt Weight Loss Clinics, Vanderbilt University Medical Center, Nashville, TN, USA.

Obesity Group, Department of Endocrinology, Universidade de São Paulo, São Paulo, Brazil.

Eli Lilly and Company, Indianapolis, IN, USA.

Eli Lilly and Company, Indianapolis, IN, USA.

Eli Lilly and Company, Indianapolis, IN, USA.

Eli Lilly and Company, Indianapolis, IN, USA.

Eli Lilly and Company, Indianapolis, IN, USA.

MeSH

HumansAdultOverweightObesityWeight LossDiabetes Mellitus, Type 2Life StyleHypoglycemic AgentsDouble-Blind MethodTirzepatideGlucagon-Like Peptide-1 Receptor Agonists

Pub Type(s)

Randomized Controlled Trial

Clinical Trial, Phase III

Journal Article

Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

37840095

Clinical Trial Links

Clinical trial which this article describes

Effectiveness and Safety of Tirzepatide Among Participants With Obesity With or Without Type 2 Diabetes Mellitus (T2DM)

Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults

Citation

Wadden, Thomas A., et al. "Tirzepatide After Intensive Lifestyle Intervention in Adults With Overweight or Obesity: the SURMOUNT-3 Phase 3 Trial." Nature Medicine, vol. 29, no. 11, 2023, pp. 2909-2918.

Wadden TA, Chao AM, Machineni S, et al. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023;29(11):2909-2918.

Wadden, T. A., Chao, A. M., Machineni, S., Kushner, R., Ard, J., Srivastava, G., Halpern, B., Zhang, S., Chen, J., Bunck, M. C., Ahmad, N. N., & Forrester, T. (2023). Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nature Medicine, 29(11), 2909-2918. https://doi.org/10.1038/s41591-023-02597-w

Wadden TA, et al. Tirzepatide After Intensive Lifestyle Intervention in Adults With Overweight or Obesity: the SURMOUNT-3 Phase 3 Trial. Nat Med. 2023;29(11):2909-2918. PubMed PMID: 37840095.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. AU - Wadden,Thomas A, AU - Chao,Ariana M, AU - Machineni,Sriram, AU - Kushner,Robert, AU - Ard,Jamy, AU - Srivastava,Gitanjali, AU - Halpern,Bruno, AU - Zhang,Shuyu, AU - Chen,Jiaxun, AU - Bunck,Mathijs C, AU - Ahmad,Nadia N, AU - Forrester,Tammy, Y1 - 2023/10/15/ PY - 2023/08/18/received PY - 2023/09/15/accepted PY - 2023/11/27/medline PY - 2023/10/16/pubmed PY - 2023/10/15/entrez SP - 2909 EP - 2918 JF - Nature medicine JO - Nat Med VL - 29 IS - 11 N2 - The effects of tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, on weight reduction after successful intensive lifestyle intervention are unknown. This double-blind, placebo-controlled trial randomized (1:1) adults with body mass index ≥30 or ≥27 kg/m[2] and at least one obesity-related complication (excluding diabetes), who achieved ≥5.0% weight reduction after a 12-week intensive lifestyle intervention, to tirzepatide maximum tolerated dose (10 or 15 mg) or placebo once weekly for 72 weeks (n = 579). The treatment regimen estimand assessed effects regardless of treatment adherence in the intention-to-treat population. The coprimary endpoint of additional mean per cent weight change from randomization to week 72 was met with changes of -18.4% (standard error (s.e.) 0.7) with tirzepatide and 2.5% (s.e. 1.0) with placebo (estimated treatment difference -20.8 percentage points (95% confidence interval (CI) -23.2%, -18.5%; P < 0.001). The coprimary endpoint of the percentage of participants achieving additional weight reduction ≥5% was met with 87.5% (s.e. 2.2) with tirzepatide and 16.5% (s.e. 3.0) with placebo achieving this threshold (odds ratio 34.6%; 95% CI 19.2%, 62.6%; P < 0.001). The most common adverse events with tirzepatide were gastrointestinal, with most being mild to moderate in severity. Tirzepatide provided substantial additional reduction in body weight in participants who had achieved ≥5.0% weight reduction with intensive lifestyle intervention. ClinicalTrials.gov registration: NCT04657016 . SN - 1546-170X UR - https://www.unboundmedicine.com/medline/citation/37840095/full_citation DB - PRIME DP - Unbound Medicine ER -