Tirzepatide Once Weekly for the Treatment of Obesity

In this randomized trial, adults with obesity treated with weekly tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, had major weight loss over 72 weeks.

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Bibliographic Details
Published in	The New England journal of medicine Vol. 387; no. 3; pp. 205 - 216
Main Authors	Jastreboff, Ania M., Aronne, Louis J., Ahmad, Nadia N., Wharton, Sean, Connery, Lisa, Alves, Breno, Kiyosue, Arihiro, Zhang, Shuyu, Liu, Bing, Bunck, Mathijs C., Stefanski, Adam
Format	Journal Article
Language	English
Published	United States Massachusetts Medical Society 21.07.2022
Subjects	Adult Adverse events Anti-Obesity Agents - administration & dosage Anti-Obesity Agents - pharmacology Anti-Obesity Agents - therapeutic use Antidiabetics Body weight Cardiovascular disease Chronic illnesses Clinical Medicine Clinical Medicine General Clinical trials Diabetes Diabetes mellitus Diet Dose-Response Relationship, Drug Double-Blind Method Endocrinology FDA approval Gastric Inhibitory Polypeptide - administration & dosage Gastric Inhibitory Polypeptide - therapeutic use Gastroenterology GIP protein GLP-1 receptor agonists Glucagon Glucagon-like peptide 1 Glucagon-Like Peptides - administration & dosage Glucagon-Like Peptides - agonists Glucagon-Like Peptides - therapeutic use Humans Injections, Subcutaneous Lifestyles Morbidity Nutrition Obesity Obesity - complications Obesity - drug therapy Overweight Peptides Placebos Statistical analysis Treatment Outcome Weight control Weight Loss - drug effects
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Abstract	In this randomized trial, adults with obesity treated with weekly tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, had major weight loss over 72 weeks.
AbstractList	Obesity is a chronic disease that results in substantial global morbidity and mortality. The efficacy and safety of tirzepatide, a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, in people with obesity are not known.BACKGROUNDObesity is a chronic disease that results in substantial global morbidity and mortality. The efficacy and safety of tirzepatide, a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, in people with obesity are not known.In this phase 3 double-blind, randomized, controlled trial, we assigned 2539 adults with a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes, in a 1:1:1:1 ratio to receive once-weekly, subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks, including a 20-week dose-escalation period. Coprimary end points were the percentage change in weight from baseline and a weight reduction of 5% or more. The treatment-regimen estimand assessed effects regardless of treatment discontinuation in the intention-to-treat population.METHODSIn this phase 3 double-blind, randomized, controlled trial, we assigned 2539 adults with a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes, in a 1:1:1:1 ratio to receive once-weekly, subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks, including a 20-week dose-escalation period. Coprimary end points were the percentage change in weight from baseline and a weight reduction of 5% or more. The treatment-regimen estimand assessed effects regardless of treatment discontinuation in the intention-to-treat population.At baseline, the mean body weight was 104.8 kg, the mean BMI was 38.0, and 94.5% of participants had a BMI of 30 or higher. The mean percentage change in weight at week 72 was -15.0% (95% confidence interval [CI], -15.9 to -14.2) with 5-mg weekly doses of tirzepatide, -19.5% (95% CI, -20.4 to -18.5) with 10-mg doses, and -20.9% (95% CI, -21.8 to -19.9) with 15-mg doses and -3.1% (95% CI, -4.3 to -1.9) with placebo (P<0.001 for all comparisons with placebo). The percentage of participants who had weight reduction of 5% or more was 85% (95% CI, 82 to 89), 89% (95% CI, 86 to 92), and 91% (95% CI, 88 to 94) with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and 35% (95% CI, 30 to 39) with placebo; 50% (95% CI, 46 to 54) and 57% (95% CI, 53 to 61) of participants in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, as compared with 3% (95% CI, 1 to 5) in the placebo group (P<0.001 for all comparisons with placebo). Improvements in all prespecified cardiometabolic measures were observed with tirzepatide. The most common adverse events with tirzepatide were gastrointestinal, and most were mild to moderate in severity, occurring primarily during dose escalation. Adverse events caused treatment discontinuation in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg tirzepatide doses and placebo, respectively.RESULTSAt baseline, the mean body weight was 104.8 kg, the mean BMI was 38.0, and 94.5% of participants had a BMI of 30 or higher. The mean percentage change in weight at week 72 was -15.0% (95% confidence interval [CI], -15.9 to -14.2) with 5-mg weekly doses of tirzepatide, -19.5% (95% CI, -20.4 to -18.5) with 10-mg doses, and -20.9% (95% CI, -21.8 to -19.9) with 15-mg doses and -3.1% (95% CI, -4.3 to -1.9) with placebo (P<0.001 for all comparisons with placebo). The percentage of participants who had weight reduction of 5% or more was 85% (95% CI, 82 to 89), 89% (95% CI, 86 to 92), and 91% (95% CI, 88 to 94) with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and 35% (95% CI, 30 to 39) with placebo; 50% (95% CI, 46 to 54) and 57% (95% CI, 53 to 61) of participants in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, as compared with 3% (95% CI, 1 to 5) in the placebo group (P<0.001 for all comparisons with placebo). Improvements in all prespecified cardiometabolic measures were observed with tirzepatide. The most common adverse events with tirzepatide were gastrointestinal, and most were mild to moderate in severity, occurring primarily during dose escalation. Adverse events caused treatment discontinuation in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg tirzepatide doses and placebo, respectively.In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body weight. (Supported by Eli Lilly; SURMOUNT-1 ClinicalTrials.gov number, NCT04184622.).CONCLUSIONSIn this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body weight. (Supported by Eli Lilly; SURMOUNT-1 ClinicalTrials.gov number, NCT04184622.). AbstractBackgroundObesity is a chronic disease that results in substantial global morbidity and mortality. The efficacy and safety of tirzepatide, a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, in people with obesity are not known.MethodsIn this phase 3 double-blind, randomized, controlled trial, we assigned 2539 adults with a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes, in a 1:1:1:1 ratio to receive once-weekly, subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks, including a 20-week dose-escalation period. Coprimary end points were the percentage change in weight from baseline and a weight reduction of 5% or more. The treatment-regimen estimand assessed effects regardless of treatment discontinuation in the intention-to-treat population.ResultsAt baseline, the mean body weight was 104.8 kg, the mean BMI was 38.0, and 94.5% of participants had a BMI of 30 or higher. The mean percentage change in weight at week 72 was −15.0% (95% confidence interval [CI], −15.9 to −14.2) with 5-mg weekly doses of tirzepatide, −19.5% (95% CI, −20.4 to −18.5) with 10-mg doses, and −20.9% (95% CI, −21.8 to −19.9) with 15-mg doses and −3.1% (95% CI, −4.3 to −1.9) with placebo (P<0.001 for all comparisons with placebo). The percentage of participants who had weight reduction of 5% or more was 85% (95% CI, 82 to 89), 89% (95% CI, 86 to 92), and 91% (95% CI, 88 to 94) with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and 35% (95% CI, 30 to 39) with placebo; 50% (95% CI, 46 to 54) and 57% (95% CI, 53 to 61) of participants in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, as compared with 3% (95% CI, 1 to 5) in the placebo group (P<0.001 for all comparisons with placebo). Improvements in all prespecified cardiometabolic measures were observed with tirzepatide. The most common adverse events with tirzepatide were gastrointestinal, and most were mild to moderate in severity, occurring primarily during dose escalation. Adverse events caused treatment discontinuation in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg tirzepatide doses and placebo, respectively.ConclusionsIn this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body weight. (Supported by Eli Lilly; SURMOUNT-1 ClinicalTrials.gov number, NCT04184622.) In this randomized trial, adults with obesity treated with weekly tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, had major weight loss over 72 weeks. Obesity is a chronic disease that results in substantial global morbidity and mortality. The efficacy and safety of tirzepatide, a novel glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist, in people with obesity are not known. In this phase 3 double-blind, randomized, controlled trial, we assigned 2539 adults with a body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of 30 or more, or 27 or more and at least one weight-related complication, excluding diabetes, in a 1:1:1:1 ratio to receive once-weekly, subcutaneous tirzepatide (5 mg, 10 mg, or 15 mg) or placebo for 72 weeks, including a 20-week dose-escalation period. Coprimary end points were the percentage change in weight from baseline and a weight reduction of 5% or more. The treatment-regimen estimand assessed effects regardless of treatment discontinuation in the intention-to-treat population. At baseline, the mean body weight was 104.8 kg, the mean BMI was 38.0, and 94.5% of participants had a BMI of 30 or higher. The mean percentage change in weight at week 72 was -15.0% (95% confidence interval [CI], -15.9 to -14.2) with 5-mg weekly doses of tirzepatide, -19.5% (95% CI, -20.4 to -18.5) with 10-mg doses, and -20.9% (95% CI, -21.8 to -19.9) with 15-mg doses and -3.1% (95% CI, -4.3 to -1.9) with placebo (P<0.001 for all comparisons with placebo). The percentage of participants who had weight reduction of 5% or more was 85% (95% CI, 82 to 89), 89% (95% CI, 86 to 92), and 91% (95% CI, 88 to 94) with 5 mg, 10 mg, and 15 mg of tirzepatide, respectively, and 35% (95% CI, 30 to 39) with placebo; 50% (95% CI, 46 to 54) and 57% (95% CI, 53 to 61) of participants in the 10-mg and 15-mg groups had a reduction in body weight of 20% or more, as compared with 3% (95% CI, 1 to 5) in the placebo group (P<0.001 for all comparisons with placebo). Improvements in all prespecified cardiometabolic measures were observed with tirzepatide. The most common adverse events with tirzepatide were gastrointestinal, and most were mild to moderate in severity, occurring primarily during dose escalation. Adverse events caused treatment discontinuation in 4.3%, 7.1%, 6.2%, and 2.6% of participants receiving 5-mg, 10-mg, and 15-mg tirzepatide doses and placebo, respectively. In this 72-week trial in participants with obesity, 5 mg, 10 mg, or 15 mg of tirzepatide once weekly provided substantial and sustained reductions in body weight. (Supported by Eli Lilly; SURMOUNT-1 ClinicalTrials.gov number, NCT04184622.).
Author	Aronne, Louis J. Liu, Bing Wharton, Sean Alves, Breno Stefanski, Adam Connery, Lisa Ahmad, Nadia N. Kiyosue, Arihiro Bunck, Mathijs C. Jastreboff, Ania M. Zhang, Shuyu
Author_xml	– sequence: 1 givenname: Ania M. surname: Jastreboff fullname: Jastreboff, Ania M. organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 2 givenname: Louis J. surname: Aronne fullname: Aronne, Louis J. organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 3 givenname: Nadia N. surname: Ahmad fullname: Ahmad, Nadia N. organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 4 givenname: Sean surname: Wharton fullname: Wharton, Sean organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 5 givenname: Lisa surname: Connery fullname: Connery, Lisa organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 6 givenname: Breno surname: Alves fullname: Alves, Breno organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 7 givenname: Arihiro surname: Kiyosue fullname: Kiyosue, Arihiro organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 8 givenname: Shuyu surname: Zhang fullname: Zhang, Shuyu organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 9 givenname: Bing surname: Liu fullname: Liu, Bing organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 10 givenname: Mathijs C. surname: Bunck fullname: Bunck, Mathijs C. organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.) – sequence: 11 givenname: Adam surname: Stefanski fullname: Stefanski, Adam organization: From the Section of Endocrinology and Metabolism, Department of Medicine, and the Section of Pediatric Endocrinology, Department of Pediatrics, Yale University School of Medicine, New Haven, CT (A.M.J.); the Comprehensive Weight Control Center, Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York (L.J.A.); Eli Lilly, Indianapolis (N.N.A., S.Z., B.L., M.C.B., A.S.); McMaster University, Hamilton, and York University and Wharton Weight Management Clinic, Toronto — all in Ontario, Canada (S.W.); Intend Research, Norman, OK (L.C.); Centro Paulista De Investigação Clínica (Cepic), Sao Paulo (B.A.); and Tokyo-Eki Center-Building Clinic, Tokyo (A.K.)
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/35658024$$D View this record in MEDLINE/PubMed
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Copyright	Copyright © 2022 Massachusetts Medical Society. All rights reserved. Copyright © 2022 Massachusetts Medical Society.
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Snippet	In this randomized trial, adults with obesity treated with weekly tirzepatide, a glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1... Obesity is a chronic disease that results in substantial global morbidity and mortality. The efficacy and safety of tirzepatide, a novel glucose-dependent... AbstractBackgroundObesity is a chronic disease that results in substantial global morbidity and mortality. The efficacy and safety of tirzepatide, a novel...
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SubjectTerms	Adult Adverse events Anti-Obesity Agents - administration & dosage Anti-Obesity Agents - pharmacology Anti-Obesity Agents - therapeutic use Antidiabetics Body weight Cardiovascular disease Chronic illnesses Clinical Medicine Clinical Medicine General Clinical trials Diabetes Diabetes mellitus Diet Dose-Response Relationship, Drug Double-Blind Method Endocrinology FDA approval Gastric Inhibitory Polypeptide - administration & dosage Gastric Inhibitory Polypeptide - therapeutic use Gastroenterology GIP protein GLP-1 receptor agonists Glucagon Glucagon-like peptide 1 Glucagon-Like Peptides - administration & dosage Glucagon-Like Peptides - agonists Glucagon-Like Peptides - therapeutic use Humans Injections, Subcutaneous Lifestyles Morbidity Nutrition Obesity Obesity - complications Obesity - drug therapy Overweight Peptides Placebos Statistical analysis Treatment Outcome Weight control Weight Loss - drug effects
SubjectTermsDisplay	Clinical Medicine Clinical Medicine General Diet/Nutrition Endocrinology Gastroenterology Obesity
Title	Tirzepatide Once Weekly for the Treatment of Obesity
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