Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program

Carel W. le Roux; Shuyu Zhang; Louis J. Aronne; Robert F. Kushner; Ariana M. Chao; Sriram Machineni; Julia Dunn; Farai B. Chigutsa; Nadia N. Ahmad; Mathijs C. Bunck

doi:10.1002/oby.23612

Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program

Carel W. le Roux, Shuyu Zhang, Louis J. Aronne, Robert F. Kushner, Ariana M. Chao, Sriram Machineni, Julia Dunn, Farai B. Chigutsa, Nadia N. Ahmad, Mathijs C. Bunck

Research output: Contribution to journal › Article › peer-review

22 Scopus citations

Abstract

Objective: Obesity is a growing global concern compounded by limited availability of effective treatment options. The SURMOUNT development program aims to evaluate the efficacy and safety of tirzepatide as an adjunct to lifestyle intervention compared with placebo on chronic weight management in adults with BMI ≥ 27 kg/m² with or without type 2 diabetes. Methods: The SURMOUNT program includes four global phase 3 trials NCT04184622 (SURMOUNT-1), NCT04657003 (SURMOUNT-2), NCT04657016 (SURMOUNT-3), and NCT04660643 (SURMOUNT-4). Participants are randomized to once-weekly subcutaneous tirzepatide versus placebo in a double-blind manner. The primary end point in all trials is the percentage change in body weight from randomization to end of treatment. Results for the primary end point for SURMOUNT-1 were published recently and results for the other trials are expected in 2023. Results: Across trials, participants have a mean age of 44.9 to 54.2 years, are mostly female (50.7% to 69.7%), and have a mean BMI of 36.1 to 38.9. Conclusions: The extensive assessment of once-weekly tirzepatide in the global SURMOUNT program will detail the clinical effects of this first-in-class glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist in chronic weight management.

Original language	English (US)
Pages (from-to)	96-110
Number of pages	15
Journal	Obesity
Volume	31
Issue number	1
DOIs	https://doi.org/10.1002/oby.23612
State	Published - Jan 2023
Externally published	Yes

ASJC Scopus subject areas

Medicine (miscellaneous)
Endocrinology, Diabetes and Metabolism
Endocrinology
Nutrition and Dietetics

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1002/oby.23612

Cite this

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title = "Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program",

abstract = "Objective: Obesity is a growing global concern compounded by limited availability of effective treatment options. The SURMOUNT development program aims to evaluate the efficacy and safety of tirzepatide as an adjunct to lifestyle intervention compared with placebo on chronic weight management in adults with BMI ≥ 27 kg/m2 with or without type 2 diabetes. Methods: The SURMOUNT program includes four global phase 3 trials NCT04184622 (SURMOUNT-1), NCT04657003 (SURMOUNT-2), NCT04657016 (SURMOUNT-3), and NCT04660643 (SURMOUNT-4). Participants are randomized to once-weekly subcutaneous tirzepatide versus placebo in a double-blind manner. The primary end point in all trials is the percentage change in body weight from randomization to end of treatment. Results for the primary end point for SURMOUNT-1 were published recently and results for the other trials are expected in 2023. Results: Across trials, participants have a mean age of 44.9 to 54.2 years, are mostly female (50.7% to 69.7%), and have a mean BMI of 36.1 to 38.9. Conclusions: The extensive assessment of once-weekly tirzepatide in the global SURMOUNT program will detail the clinical effects of this first-in-class glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist in chronic weight management.",

author = "{le Roux}, {Carel W.} and Shuyu Zhang and Aronne, {Louis J.} and Kushner, {Robert F.} and Chao, {Ariana M.} and Sriram Machineni and Julia Dunn and Chigutsa, {Farai B.} and Ahmad, {Nadia N.} and Bunck, {Mathijs C.}",

note = "Publisher Copyright: {\textcopyright} 2022 Eli Lilly and Company. Obesity published by Wiley Periodicals LLC on behalf of The Obesity Society.",

year = "2023",

month = jan,

doi = "10.1002/oby.23612",

language = "English (US)",

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pages = "96--110",

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T2 - Rationale and design of the SURMOUNT clinical development program

AU - le Roux, Carel W.

AU - Zhang, Shuyu

AU - Aronne, Louis J.

AU - Kushner, Robert F.

AU - Chao, Ariana M.

AU - Machineni, Sriram

AU - Dunn, Julia

AU - Chigutsa, Farai B.

AU - Ahmad, Nadia N.

AU - Bunck, Mathijs C.

PY - 2023/1

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N2 - Objective: Obesity is a growing global concern compounded by limited availability of effective treatment options. The SURMOUNT development program aims to evaluate the efficacy and safety of tirzepatide as an adjunct to lifestyle intervention compared with placebo on chronic weight management in adults with BMI ≥ 27 kg/m2 with or without type 2 diabetes. Methods: The SURMOUNT program includes four global phase 3 trials NCT04184622 (SURMOUNT-1), NCT04657003 (SURMOUNT-2), NCT04657016 (SURMOUNT-3), and NCT04660643 (SURMOUNT-4). Participants are randomized to once-weekly subcutaneous tirzepatide versus placebo in a double-blind manner. The primary end point in all trials is the percentage change in body weight from randomization to end of treatment. Results for the primary end point for SURMOUNT-1 were published recently and results for the other trials are expected in 2023. Results: Across trials, participants have a mean age of 44.9 to 54.2 years, are mostly female (50.7% to 69.7%), and have a mean BMI of 36.1 to 38.9. Conclusions: The extensive assessment of once-weekly tirzepatide in the global SURMOUNT program will detail the clinical effects of this first-in-class glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist in chronic weight management.

AB - Objective: Obesity is a growing global concern compounded by limited availability of effective treatment options. The SURMOUNT development program aims to evaluate the efficacy and safety of tirzepatide as an adjunct to lifestyle intervention compared with placebo on chronic weight management in adults with BMI ≥ 27 kg/m2 with or without type 2 diabetes. Methods: The SURMOUNT program includes four global phase 3 trials NCT04184622 (SURMOUNT-1), NCT04657003 (SURMOUNT-2), NCT04657016 (SURMOUNT-3), and NCT04660643 (SURMOUNT-4). Participants are randomized to once-weekly subcutaneous tirzepatide versus placebo in a double-blind manner. The primary end point in all trials is the percentage change in body weight from randomization to end of treatment. Results for the primary end point for SURMOUNT-1 were published recently and results for the other trials are expected in 2023. Results: Across trials, participants have a mean age of 44.9 to 54.2 years, are mostly female (50.7% to 69.7%), and have a mean BMI of 36.1 to 38.9. Conclusions: The extensive assessment of once-weekly tirzepatide in the global SURMOUNT program will detail the clinical effects of this first-in-class glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist in chronic weight management.

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Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program

Abstract

ASJC Scopus subject areas

UN SDGs

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