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This phase 2 study evaluated the safety and efficacy of JNJ\u201064565111, a dual agonist of GLP\u20101 and glucagon receptors, in individuals with T2DM and class II\/III obesity. In this randomized, double\u2010blind study, participants with T2DM (HbA1c 6.5%\u20109.5%), body mass index of 35 to 50\u2009kg\/m<jats:sup>2<\/jats:sup> and stable weight were randomly assigned (1:1:1:1) to placebo or JNJ\u201064565111 (5.0 mg, 7.4 mg or 10.0 mg). The primary endpoint was percent change from baseline in body weight at week 12. Of 195 dosed participants, 144 (73.8%) completed treatment. At week 12, placebo\u2010subtracted body weight changes were \u22124.6%, \u22125.9% and \u22127.2% with JNJ\u201064565111 5.0 mg, 7.4 mg and 10.0 mg, respectively. All JNJ\u201064565111 doses were associated with no change in HbA1c and slight numerical elevation of fasting insulin. Numerical increases in fasting plasma glucose were observed with JNJ\u201064565111 5.0 mg and 7.4 mg. Incidence of treatment\u2010emergent adverse events, especially nausea and vomiting, was higher with JNJ\u201064565111 vs placebo. Overall, JNJ\u201064565111 significantly reduced body weight in a dose\u2010dependent manner vs placebo but was associated with greater incidence of treatment\u2010emergent adverse events, no HbA1c reductions, and increased fasting plasma glucose and fasting insulin.<\/jats:p>","DOI":"10.1111\/cob.12433","type":"journal-article","created":{"date-parts":[[2021,1,21]],"date-time":"2021-01-21T18:55:17Z","timestamp":1611255317000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":59,"title":["Efficacy and safety of glucagon\u2010like peptide\u20101\/glucagon receptor co\u2010agonist <scp>JNJ<\/scp>\u201064565111 in individuals with type 2 diabetes mellitus and obesity: A randomized dose\u2010ranging study"],"prefix":"10.1111","volume":"11","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8231-6241","authenticated-orcid":false,"given":"Nicholas A.","family":"Di Prospero","sequence":"first","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaqueline","family":"Yee","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary E.","family":"Frustaci","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahesh N.","family":"Samtani","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Alba","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3597-975X","authenticated-orcid":false,"given":"Penny","family":"Fleck","sequence":"additional","affiliation":[{"name":"Janssen Research &amp; Development, LLC  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2021,1,21]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.113905"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI10842"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.17.9.961"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1136\/jech.54.8.596"},{"key":"e_1_2_9_6_1","unstructured":"World Health Organization.Obesity and overweight;2020. 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