Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program
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 adul...
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| Veröffentlicht in: | Obesity (Silver Spring, Md.) Md.), 2023-01, Vol.31 (1), p.96-110 |
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| creator | Roux, Carel W. Zhang, Shuyu Aronne, Louis J. Kushner, Robert F. Chao, Ariana M. Machineni, Sriram Dunn, Julia Chigutsa, Farai B. Ahmad, Nadia N. Bunck, Mathijs C. |
| description | 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. |
| doi_str_mv | 10.1002/oby.23612 |
| format | Article |
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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.</description><identifier>ISSN: 1930-7381</identifier><identifier>EISSN: 1930-739X</identifier><identifier>DOI: 10.1002/oby.23612</identifier><identifier>PMID: 36478180</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>Adult ; Antidiabetics ; Blood Glucose ; Clinical trials ; Diabetes ; Diabetes Mellitus, Type 2 - complications ; Diet ; Drug dosages ; Exercise ; FDA approval ; Female ; Gastric Inhibitory Polypeptide - therapeutic use ; Gastrointestinal surgery ; GLP-1 receptor agonists ; Glucagon ; Glucagon-Like Peptide-1 Receptor - agonists ; Humans ; Hypoglycemic Agents - therapeutic use ; Intervention ; Lifestyles ; Male ; Metabolism ; Middle Aged ; Obesity ; Obesity - drug therapy ; Original ; ORIGINAL ARTICLES ; Physical fitness ; Polypeptides ; Regulatory approval ; Weight control</subject><ispartof>Obesity (Silver Spring, Md.), 2023-01, Vol.31 (1), p.96-110</ispartof><rights>2022 Eli Lilly and Company. published by Wiley Periodicals LLC on behalf of The Obesity Society.</rights><rights>2022 Eli Lilly and Company. Obesity published by Wiley Periodicals LLC on behalf of The Obesity Society.</rights><rights>Copyright Blackwell Publishing Ltd. Jan 2023</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4442-10e23bdcad92f23f5d45694188fc081ce2af24778c442720c0fdf54427f0a5583</citedby><cites>FETCH-LOGICAL-c4442-10e23bdcad92f23f5d45694188fc081ce2af24778c442720c0fdf54427f0a5583</cites><orcidid>0000-0002-1380-3705 ; 0000-0001-5521-5445 ; 0000-0001-5633-8973 ; 0000-0002-9890-9401 ; 0000-0002-2862-6705</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Foby.23612$$EPDF$$P50$$Gwiley$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Foby.23612$$EHTML$$P50$$Gwiley$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,1411,1427,27901,27902,45550,45551,46384,46808</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36478180$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Roux, Carel W.</creatorcontrib><creatorcontrib>Zhang, Shuyu</creatorcontrib><creatorcontrib>Aronne, Louis J.</creatorcontrib><creatorcontrib>Kushner, Robert F.</creatorcontrib><creatorcontrib>Chao, Ariana M.</creatorcontrib><creatorcontrib>Machineni, Sriram</creatorcontrib><creatorcontrib>Dunn, Julia</creatorcontrib><creatorcontrib>Chigutsa, Farai B.</creatorcontrib><creatorcontrib>Ahmad, Nadia N.</creatorcontrib><creatorcontrib>Bunck, Mathijs C.</creatorcontrib><title>Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program</title><title>Obesity (Silver Spring, Md.)</title><addtitle>Obesity (Silver Spring)</addtitle><description>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.</description><subject>Adult</subject><subject>Antidiabetics</subject><subject>Blood Glucose</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>Diet</subject><subject>Drug dosages</subject><subject>Exercise</subject><subject>FDA approval</subject><subject>Female</subject><subject>Gastric Inhibitory Polypeptide - therapeutic use</subject><subject>Gastrointestinal surgery</subject><subject>GLP-1 receptor agonists</subject><subject>Glucagon</subject><subject>Glucagon-Like Peptide-1 Receptor - agonists</subject><subject>Humans</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Intervention</subject><subject>Lifestyles</subject><subject>Male</subject><subject>Metabolism</subject><subject>Middle Aged</subject><subject>Obesity</subject><subject>Obesity - drug therapy</subject><subject>Original</subject><subject>ORIGINAL ARTICLES</subject><subject>Physical fitness</subject><subject>Polypeptides</subject><subject>Regulatory approval</subject><subject>Weight control</subject><issn>1930-7381</issn><issn>1930-739X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>EIF</sourceid><recordid>eNp1kV1vFCEUhkmjaWv1wj9gSLzRi20PMMwwvTHa-JXUblJ3k_aKsAxsaZlhhNma9dfL7NaNNvGKE87Dkze8CL0kcEwA6ElYrI8pKwndQ4ekZjCpWH31ZDcLcoCepXQLUJTAyT46YGVRCSLgEN3NXPxlejW4xmAbIh5uDB6iUUNrugEHi8PCJDesT_FlhkKnvMGqa3CTb5fdCIwvvs8vv03nFzOsveucVj7v740P_cbSx7CMqn2Onlrlk3nxcB6h-aePs7Mvk_Pp569n788nuigKOiFgKFs0WjU1tZRZ3hS8rAsihNUgiDZUWVpUlcg4rShosI3l42xBcS7YEXq39farRWsanSNE5WUfXaviWgbl5L-bzt3IZbiXBAhUHEg2vHkwxPBjZdIgW5e08V51JqySpBVnDGohqoy-foTehlXM37Sh6pILTsdIb7eUjiGlaOwuDQE5dihzh3LTYWZf_R1_R_4pLQMnW-Cn82b9f5OcfrjeKn8DzV6mjg</recordid><startdate>202301</startdate><enddate>202301</enddate><creator>Roux, Carel W.</creator><creator>Zhang, Shuyu</creator><creator>Aronne, Louis J.</creator><creator>Kushner, Robert F.</creator><creator>Chao, Ariana M.</creator><creator>Machineni, Sriram</creator><creator>Dunn, Julia</creator><creator>Chigutsa, Farai B.</creator><creator>Ahmad, Nadia N.</creator><creator>Bunck, Mathijs C.</creator><general>Blackwell Publishing Ltd</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-1380-3705</orcidid><orcidid>https://orcid.org/0000-0001-5521-5445</orcidid><orcidid>https://orcid.org/0000-0001-5633-8973</orcidid><orcidid>https://orcid.org/0000-0002-9890-9401</orcidid><orcidid>https://orcid.org/0000-0002-2862-6705</orcidid></search><sort><creationdate>202301</creationdate><title>Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program</title><author>Roux, Carel W. ; Zhang, Shuyu ; Aronne, Louis J. ; Kushner, Robert F. ; Chao, Ariana M. ; Machineni, Sriram ; Dunn, Julia ; Chigutsa, Farai B. ; Ahmad, Nadia N. ; Bunck, Mathijs C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4442-10e23bdcad92f23f5d45694188fc081ce2af24778c442720c0fdf54427f0a5583</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Antidiabetics</topic><topic>Blood Glucose</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Diet</topic><topic>Drug dosages</topic><topic>Exercise</topic><topic>FDA approval</topic><topic>Female</topic><topic>Gastric Inhibitory Polypeptide - therapeutic use</topic><topic>Gastrointestinal surgery</topic><topic>GLP-1 receptor agonists</topic><topic>Glucagon</topic><topic>Glucagon-Like Peptide-1 Receptor - agonists</topic><topic>Humans</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Intervention</topic><topic>Lifestyles</topic><topic>Male</topic><topic>Metabolism</topic><topic>Middle Aged</topic><topic>Obesity</topic><topic>Obesity - drug therapy</topic><topic>Original</topic><topic>ORIGINAL ARTICLES</topic><topic>Physical fitness</topic><topic>Polypeptides</topic><topic>Regulatory approval</topic><topic>Weight control</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Roux, Carel W.</creatorcontrib><creatorcontrib>Zhang, Shuyu</creatorcontrib><creatorcontrib>Aronne, Louis J.</creatorcontrib><creatorcontrib>Kushner, Robert F.</creatorcontrib><creatorcontrib>Chao, Ariana M.</creatorcontrib><creatorcontrib>Machineni, Sriram</creatorcontrib><creatorcontrib>Dunn, Julia</creatorcontrib><creatorcontrib>Chigutsa, Farai B.</creatorcontrib><creatorcontrib>Ahmad, Nadia N.</creatorcontrib><creatorcontrib>Bunck, Mathijs C.</creatorcontrib><collection>Wiley Online Library Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Obesity (Silver Spring, Md.)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Roux, Carel W.</au><au>Zhang, Shuyu</au><au>Aronne, Louis J.</au><au>Kushner, Robert F.</au><au>Chao, Ariana M.</au><au>Machineni, Sriram</au><au>Dunn, Julia</au><au>Chigutsa, Farai B.</au><au>Ahmad, Nadia N.</au><au>Bunck, Mathijs C.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program</atitle><jtitle>Obesity (Silver Spring, Md.)</jtitle><addtitle>Obesity (Silver Spring)</addtitle><date>2023-01</date><risdate>2023</risdate><volume>31</volume><issue>1</issue><spage>96</spage><epage>110</epage><pages>96-110</pages><issn>1930-7381</issn><eissn>1930-739X</eissn><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.</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>36478180</pmid><doi>10.1002/oby.23612</doi><tpages>15</tpages><orcidid>https://orcid.org/0000-0002-1380-3705</orcidid><orcidid>https://orcid.org/0000-0001-5521-5445</orcidid><orcidid>https://orcid.org/0000-0001-5633-8973</orcidid><orcidid>https://orcid.org/0000-0002-9890-9401</orcidid><orcidid>https://orcid.org/0000-0002-2862-6705</orcidid><oa>free_for_read</oa></addata></record> |
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| source | Wiley Free Content; MEDLINE; Wiley Online Library Journals Frontfile Complete |
| subjects | Adult Antidiabetics Blood Glucose Clinical trials Diabetes Diabetes Mellitus, Type 2 - complications Diet Drug dosages Exercise FDA approval Female Gastric Inhibitory Polypeptide - therapeutic use Gastrointestinal surgery GLP-1 receptor agonists Glucagon Glucagon-Like Peptide-1 Receptor - agonists Humans Hypoglycemic Agents - therapeutic use Intervention Lifestyles Male Metabolism Middle Aged Obesity Obesity - drug therapy Original ORIGINAL ARTICLES Physical fitness Polypeptides Regulatory approval Weight control |
| title | Tirzepatide for the treatment of obesity: Rationale and design of the SURMOUNT clinical development program |
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