Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study
Summary Background The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes. Methods We did a double-blind, placebo-...
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| Veröffentlicht in: | The Lancet (British edition) 2009-11, Vol.374 (9701), p.1606-1616 |
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| creator | Astrup, Arne, Prof Rössner, Stephan, Prof Van Gaal, Luc, Prof Rissanen, Aila, Prof Niskanen, Leo, Prof Al Hakim, Mazin, MD Madsen, Jesper, PhD Rasmussen, Mads F, PhD Lean, Michael EJ, Prof |
| description | Summary Background The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes. Methods We did a double-blind, placebo-controlled 20-week trial, with open-label orlistat comparator in 19 sites in Europe. 564 individuals (18–65 years of age, body-mass index 30–40 kg/m2 ) were randomly assigned, with a telephone or web-based system, to one of four liraglutide doses (1·2 mg, 1·8 mg, 2·4 mg, or 3·0 mg, n=90–95) or to placebo (n=98) administered once a day subcutaneously, or orlistat (120 mg, n=95) three times a day orally. All individuals had a 500 kcal per day energy-deficit diet and increased their physical activity throughout the trial, including the 2-week run-in. Weight change analysed by intention to treat was the primary endpoint. An 84-week open-label extension followed. This study is registered with ClinicalTrials.gov , number NCT00422058. Findings Participants on liraglutide lost significantly more weight than did those on placebo (p=0·003 for liraglutide 1·2 mg and p |
| doi_str_mv | 10.1016/S0140-6736(09)61375-1 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_733940476</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0140673609613751</els_id><sourcerecordid>1898636021</sourcerecordid><originalsourceid>FETCH-LOGICAL-c559t-5a0103f3775e5b27e8dfef787ab8eb5d63e99c5bc1a4be34f9561cf9716193e63</originalsourceid><addsrcrecordid>eNqFkV1rFDEUhgdR7Lb6E5RB8AscTSZfEy8qUuoHFLxQwbuQSU5sanayJhlh_72Z3aWFXuhVCHnOm3PO0zSPMHqNEeZvviJMUccF4S-QfMkxEazDd5oVpoJ2jIofd5vVNXLUHOd8hRCiHLH7zRGWAyMS8VVzee4cmJLb6Nrgk_4Z5uIttH5qyyW0JYEua5jK8h5HyL5s37a6TXqyce0z2FetjfMYoBuDn-ptE7SBMXYmTiXFEMC2ucx2-6C553TI8PBwnjTfP5x_O_vUXXz5-Pns_UVnGJOlYxphRBwRggEbewGDdeDEIPQ4wMgsJyClYaPBmo5AqJOMY-OkwBxLApycNM_3uZsUf8-Qi6ptGghBTxDnrAQhkiIqFvLZP8ke9z0WnFXwyS3wKs5pqlMoLCWiQ89khdgeMinmnMCpTfJrnbYKI7UYUztjatGhkFQ7YwrXuseH8Hlcg72pOiiqwNMDoLPRwdXVG5-vub5HdR5EK_duz0Hd7h8PSWXjYTJgfaqGlY3-v62c3kow1amvn_6CLeSboVXuFdqHLBlI7hIw-QtoBscN</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>199048259</pqid></control><display><type>article</type><title>Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals</source><creator>Astrup, Arne, Prof ; Rössner, Stephan, Prof ; Van Gaal, Luc, Prof ; Rissanen, Aila, Prof ; Niskanen, Leo, Prof ; Al Hakim, Mazin, MD ; Madsen, Jesper, PhD ; Rasmussen, Mads F, PhD ; Lean, Michael EJ, Prof</creator><creatorcontrib>Astrup, Arne, Prof ; Rössner, Stephan, Prof ; Van Gaal, Luc, Prof ; Rissanen, Aila, Prof ; Niskanen, Leo, Prof ; Al Hakim, Mazin, MD ; Madsen, Jesper, PhD ; Rasmussen, Mads F, PhD ; Lean, Michael EJ, Prof ; on behalf of the NN8022-1807 Study Group ; NN8022-1807 Study Group</creatorcontrib><description>Summary Background The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes. Methods We did a double-blind, placebo-controlled 20-week trial, with open-label orlistat comparator in 19 sites in Europe. 564 individuals (18–65 years of age, body-mass index 30–40 kg/m2 ) were randomly assigned, with a telephone or web-based system, to one of four liraglutide doses (1·2 mg, 1·8 mg, 2·4 mg, or 3·0 mg, n=90–95) or to placebo (n=98) administered once a day subcutaneously, or orlistat (120 mg, n=95) three times a day orally. All individuals had a 500 kcal per day energy-deficit diet and increased their physical activity throughout the trial, including the 2-week run-in. Weight change analysed by intention to treat was the primary endpoint. An 84-week open-label extension followed. This study is registered with ClinicalTrials.gov , number NCT00422058. Findings Participants on liraglutide lost significantly more weight than did those on placebo (p=0·003 for liraglutide 1·2 mg and p<0·0001 for liraglutide 1·8–3·0 mg) and orlistat (p=0·003 for liraglutide 2·4 mg and p<0·0001 for liraglutide 3·0 mg). Mean weight loss with liraglutide 1·2–3·0 mg was 4·8 kg, 5·5 kg, 6·3 kg, and 7·2 kg compared with 2·8 kg with placebo and 4·1 kg with orlistat, and was 2·1 kg (95% CI 0·6–3·6) to 4·4 kg (2·9–6·0) greater than that with placebo. More individuals (76%, n=70) lost more than 5% weight with liraglutide 3·0 mg that with placebo (30%, n=29) or orlistat (44%, n=42). Liraglutide reduced blood pressure at all doses, and reduced the prevalence of prediabetes (84–96% reduction) with 1·8–3·0 mg per day. Nausea and vomiting occurred more often in individuals on liraglutide than in those on placebo, but adverse events were mainly transient and rarely led to discontinuation of treatment. Interpretation Liraglutide treatment over 20 weeks is well tolerated, induces weight loss, improves certain obesity-related risk factors, and reduces prediabetes. Funding Novo Nordisk A/S, Bagsvaerd, Denmark.</description><identifier>ISSN: 0140-6736</identifier><identifier>EISSN: 1474-547X</identifier><identifier>DOI: 10.1016/S0140-6736(09)61375-1</identifier><identifier>PMID: 19853906</identifier><identifier>CODEN: LANCAO</identifier><language>eng</language><publisher>Kidlington: Elsevier Ltd</publisher><subject>Analysis of Variance ; Anti-Obesity Agents - therapeutic use ; Biological and medical sciences ; Blood pressure ; Body Mass Index ; Clinical medicine ; Diabetes ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug therapy ; Europe - epidemiology ; Female ; General aspects ; Glucagon-Like Peptide 1 - analogs & derivatives ; Glucagon-Like Peptide 1 - pharmacology ; Glucagon-Like Peptide 1 - therapeutic use ; Humans ; Injections, Subcutaneous ; Internal Medicine ; Lactones - therapeutic use ; Liraglutide ; Logistic Models ; Male ; Medical sciences ; Metabolic diseases ; Metabolic syndrome ; Mortality ; Nausea ; Obesity ; Obesity - complications ; Obesity - drug therapy ; Obesity - epidemiology ; Prediabetic State - complications ; Prediabetic State - prevention & control ; Risk factors ; Safety ; Studies ; Treatment Outcome ; Waist Circumference - drug effects ; Weight control ; Weight Loss - drug effects</subject><ispartof>The Lancet (British edition), 2009-11, Vol.374 (9701), p.1606-1616</ispartof><rights>Elsevier Ltd</rights><rights>2009 Elsevier Ltd</rights><rights>2009 INIST-CNRS</rights><rights>Copyright Elsevier Limited Nov 7-Nov 13, 2009</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c559t-5a0103f3775e5b27e8dfef787ab8eb5d63e99c5bc1a4be34f9561cf9716193e63</citedby><cites>FETCH-LOGICAL-c559t-5a0103f3775e5b27e8dfef787ab8eb5d63e99c5bc1a4be34f9561cf9716193e63</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0140673609613751$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22094004$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19853906$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Astrup, Arne, Prof</creatorcontrib><creatorcontrib>Rössner, Stephan, Prof</creatorcontrib><creatorcontrib>Van Gaal, Luc, Prof</creatorcontrib><creatorcontrib>Rissanen, Aila, Prof</creatorcontrib><creatorcontrib>Niskanen, Leo, Prof</creatorcontrib><creatorcontrib>Al Hakim, Mazin, MD</creatorcontrib><creatorcontrib>Madsen, Jesper, PhD</creatorcontrib><creatorcontrib>Rasmussen, Mads F, PhD</creatorcontrib><creatorcontrib>Lean, Michael EJ, Prof</creatorcontrib><creatorcontrib>on behalf of the NN8022-1807 Study Group</creatorcontrib><creatorcontrib>NN8022-1807 Study Group</creatorcontrib><title>Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study</title><title>The Lancet (British edition)</title><addtitle>Lancet</addtitle><description>Summary Background The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes. Methods We did a double-blind, placebo-controlled 20-week trial, with open-label orlistat comparator in 19 sites in Europe. 564 individuals (18–65 years of age, body-mass index 30–40 kg/m2 ) were randomly assigned, with a telephone or web-based system, to one of four liraglutide doses (1·2 mg, 1·8 mg, 2·4 mg, or 3·0 mg, n=90–95) or to placebo (n=98) administered once a day subcutaneously, or orlistat (120 mg, n=95) three times a day orally. All individuals had a 500 kcal per day energy-deficit diet and increased their physical activity throughout the trial, including the 2-week run-in. Weight change analysed by intention to treat was the primary endpoint. An 84-week open-label extension followed. This study is registered with ClinicalTrials.gov , number NCT00422058. Findings Participants on liraglutide lost significantly more weight than did those on placebo (p=0·003 for liraglutide 1·2 mg and p<0·0001 for liraglutide 1·8–3·0 mg) and orlistat (p=0·003 for liraglutide 2·4 mg and p<0·0001 for liraglutide 3·0 mg). Mean weight loss with liraglutide 1·2–3·0 mg was 4·8 kg, 5·5 kg, 6·3 kg, and 7·2 kg compared with 2·8 kg with placebo and 4·1 kg with orlistat, and was 2·1 kg (95% CI 0·6–3·6) to 4·4 kg (2·9–6·0) greater than that with placebo. More individuals (76%, n=70) lost more than 5% weight with liraglutide 3·0 mg that with placebo (30%, n=29) or orlistat (44%, n=42). Liraglutide reduced blood pressure at all doses, and reduced the prevalence of prediabetes (84–96% reduction) with 1·8–3·0 mg per day. Nausea and vomiting occurred more often in individuals on liraglutide than in those on placebo, but adverse events were mainly transient and rarely led to discontinuation of treatment. Interpretation Liraglutide treatment over 20 weeks is well tolerated, induces weight loss, improves certain obesity-related risk factors, and reduces prediabetes. Funding Novo Nordisk A/S, Bagsvaerd, Denmark.</description><subject>Analysis of Variance</subject><subject>Anti-Obesity Agents - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Blood pressure</subject><subject>Body Mass Index</subject><subject>Clinical medicine</subject><subject>Diabetes</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Europe - epidemiology</subject><subject>Female</subject><subject>General aspects</subject><subject>Glucagon-Like Peptide 1 - analogs & derivatives</subject><subject>Glucagon-Like Peptide 1 - pharmacology</subject><subject>Glucagon-Like Peptide 1 - therapeutic use</subject><subject>Humans</subject><subject>Injections, Subcutaneous</subject><subject>Internal Medicine</subject><subject>Lactones - therapeutic use</subject><subject>Liraglutide</subject><subject>Logistic Models</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Metabolic diseases</subject><subject>Metabolic syndrome</subject><subject>Mortality</subject><subject>Nausea</subject><subject>Obesity</subject><subject>Obesity - complications</subject><subject>Obesity - drug therapy</subject><subject>Obesity - epidemiology</subject><subject>Prediabetic State - complications</subject><subject>Prediabetic State - prevention & control</subject><subject>Risk factors</subject><subject>Safety</subject><subject>Studies</subject><subject>Treatment Outcome</subject><subject>Waist Circumference - drug effects</subject><subject>Weight control</subject><subject>Weight Loss - drug 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of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study</title><author>Astrup, Arne, Prof ; Rössner, Stephan, Prof ; Van Gaal, Luc, Prof ; Rissanen, Aila, Prof ; Niskanen, Leo, Prof ; Al Hakim, Mazin, MD ; Madsen, Jesper, PhD ; Rasmussen, Mads F, PhD ; Lean, Michael EJ, Prof</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c559t-5a0103f3775e5b27e8dfef787ab8eb5d63e99c5bc1a4be34f9561cf9716193e63</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Analysis of Variance</topic><topic>Anti-Obesity Agents - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Blood pressure</topic><topic>Body Mass Index</topic><topic>Clinical medicine</topic><topic>Diabetes</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Europe - 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edition)</jtitle><addtitle>Lancet</addtitle><date>2009-11-07</date><risdate>2009</risdate><volume>374</volume><issue>9701</issue><spage>1606</spage><epage>1616</epage><pages>1606-1616</pages><issn>0140-6736</issn><eissn>1474-547X</eissn><coden>LANCAO</coden><abstract>Summary Background The frequency of obesity has risen dramatically in recent years but only few safe and effective drugs are currently available. We assessed the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes. Methods We did a double-blind, placebo-controlled 20-week trial, with open-label orlistat comparator in 19 sites in Europe. 564 individuals (18–65 years of age, body-mass index 30–40 kg/m2 ) were randomly assigned, with a telephone or web-based system, to one of four liraglutide doses (1·2 mg, 1·8 mg, 2·4 mg, or 3·0 mg, n=90–95) or to placebo (n=98) administered once a day subcutaneously, or orlistat (120 mg, n=95) three times a day orally. All individuals had a 500 kcal per day energy-deficit diet and increased their physical activity throughout the trial, including the 2-week run-in. Weight change analysed by intention to treat was the primary endpoint. An 84-week open-label extension followed. This study is registered with ClinicalTrials.gov , number NCT00422058. Findings Participants on liraglutide lost significantly more weight than did those on placebo (p=0·003 for liraglutide 1·2 mg and p<0·0001 for liraglutide 1·8–3·0 mg) and orlistat (p=0·003 for liraglutide 2·4 mg and p<0·0001 for liraglutide 3·0 mg). Mean weight loss with liraglutide 1·2–3·0 mg was 4·8 kg, 5·5 kg, 6·3 kg, and 7·2 kg compared with 2·8 kg with placebo and 4·1 kg with orlistat, and was 2·1 kg (95% CI 0·6–3·6) to 4·4 kg (2·9–6·0) greater than that with placebo. More individuals (76%, n=70) lost more than 5% weight with liraglutide 3·0 mg that with placebo (30%, n=29) or orlistat (44%, n=42). Liraglutide reduced blood pressure at all doses, and reduced the prevalence of prediabetes (84–96% reduction) with 1·8–3·0 mg per day. Nausea and vomiting occurred more often in individuals on liraglutide than in those on placebo, but adverse events were mainly transient and rarely led to discontinuation of treatment. Interpretation Liraglutide treatment over 20 weeks is well tolerated, induces weight loss, improves certain obesity-related risk factors, and reduces prediabetes. Funding Novo Nordisk A/S, Bagsvaerd, Denmark.</abstract><cop>Kidlington</cop><pub>Elsevier Ltd</pub><pmid>19853906</pmid><doi>10.1016/S0140-6736(09)61375-1</doi><tpages>11</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0140-6736 |
| ispartof | The Lancet (British edition), 2009-11, Vol.374 (9701), p.1606-1616 |
| issn | 0140-6736 1474-547X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_733940476 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Analysis of Variance Anti-Obesity Agents - therapeutic use Biological and medical sciences Blood pressure Body Mass Index Clinical medicine Diabetes Dose-Response Relationship, Drug Double-Blind Method Drug therapy Europe - epidemiology Female General aspects Glucagon-Like Peptide 1 - analogs & derivatives Glucagon-Like Peptide 1 - pharmacology Glucagon-Like Peptide 1 - therapeutic use Humans Injections, Subcutaneous Internal Medicine Lactones - therapeutic use Liraglutide Logistic Models Male Medical sciences Metabolic diseases Metabolic syndrome Mortality Nausea Obesity Obesity - complications Obesity - drug therapy Obesity - epidemiology Prediabetic State - complications Prediabetic State - prevention & control Risk factors Safety Studies Treatment Outcome Waist Circumference - drug effects Weight control Weight Loss - drug effects |
| title | Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-01-29T11%3A14%3A11IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effects%20of%20liraglutide%20in%20the%20treatment%20of%20obesity:%20a%20randomised,%20double-blind,%20placebo-controlled%20study&rft.jtitle=The%20Lancet%20(British%20edition)&rft.au=Astrup,%20Arne,%20Prof&rft.aucorp=on%20behalf%20of%20the%20NN8022-1807%20Study%20Group&rft.date=2009-11-07&rft.volume=374&rft.issue=9701&rft.spage=1606&rft.epage=1616&rft.pages=1606-1616&rft.issn=0140-6736&rft.eissn=1474-547X&rft.coden=LANCAO&rft_id=info:doi/10.1016/S0140-6736(09)61375-1&rft_dat=%3Cproquest_cross%3E1898636021%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=199048259&rft_id=info:pmid/19853906&rft_els_id=S0140673609613751&rfr_iscdi=true |