{"id":32693,"date":"2025-07-09T15:40:50","date_gmt":"2025-07-09T10:10:50","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=32693"},"modified":"2025-07-09T15:45:52","modified_gmt":"2025-07-09T10:15:52","slug":"maritide-phase-ii-trial","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/maritide-phase-ii-trial","title":{"rendered":"Once-monthly MariTide for the Treatment of Obesity in People with or without T2D: A 52-Week Phase II Study"},"content":{"rendered":"\n<ul class=\"wp-block-list\">\n<li><em>MariTide is a novel peptide-antibody conjugate designed to treat obesity and T2Ds by activating GLP-1 receptors and blocking GIP receptors. Its dual mechanism and long half-life may enhance durability and help prevent weight regain.&nbsp;<\/em><\/li>\n\n\n\n<li><em>Preclinical studies show greater weight loss with this combined approach than with GLP-1 or GIP targeting alone.<\/em><\/li>\n<\/ul>\n\n\n\n<p><strong>Summary<\/strong><\/p>\n\n\n\n<p>Amgen\u2019s Phase\u202fII trial (NCT05669599) of MariTide (maridebart cafraglutide), a monthly peptide\u2011antibody conjugate targeting GLP\u20111 activation and GIP inhibition, demonstrated strong and ongoing weight loss\u2014including up to <strong>~20%<\/strong> in people with obesity without diabetes and <strong>~17%<\/strong> in those with T2D\u2014alongside cardiometabolic improvements. A lower-dose initiation approach significantly improved tolerability without affecting efficacy. These findings are now guiding a 72-week Phase\u202fIII program and several outcomes studies.<\/p>\n\n\n\n<p><strong>Trial Design<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Participants<\/strong>: 592 adults; Cohort A: obesity without T2D (n\u202f=\u202f465), Cohort B: obesity with T2D (n\u202f=\u202f127).<\/li>\n\n\n\n<li><strong>Dosing arms<\/strong>: three fixed monthly doses (140\u202fmg, 280\u202fmg, 420\u202fmg), a high-dose direct arm, and two dose-escalation arms starting lower (70\u2013420\u202fmg) over four or twelve weeks.<\/li>\n\n\n\n<li><strong>Evaluation period<\/strong>: 52 weeks plus optional continuation into Part\u202f2 assessing durability and less-frequent dosing.<\/li>\n\n\n\n<li><strong>Endpoints<\/strong>: Weight change measured via treatment-policy (ITT) and efficacy estimands; additional measures included HbA1c, waist circumference, blood pressure, hs-CRP, and lipids.<\/li>\n<\/ul>\n\n\n\n<p><strong>Results<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Weight loss<\/strong>: In <strong>Cohort A<\/strong>, ITT analyses <strong>showed 12.3\u201316.2% average weight reduction<\/strong>; efficacy estimand reached 16.3\u201319.9%. In <strong>Cohort B<\/strong>, <strong>8.4\u201312.3% (ITT)<\/strong> and 12.1\u201317.0% (efficacy). Notably, <strong>weight loss remained ongoing at 52 weeks<\/strong>, with no plateau observed.<\/li>\n\n\n\n<li><strong>Glycemic control<\/strong>: T2D participants had <strong>reductions in HbA1c<\/strong> of up to 2.2% points.<\/li>\n\n\n\n<li><strong>Cardiometabolic benefits<\/strong>: Significant improvements were seen in waist circumference, blood pressure, hs-CRP, and select lipid levels.<\/li>\n\n\n\n<li><strong>Safety and tolerability<\/strong>: No new safety signals; GI side effects common but mainly mild\/moderate. Dose-escalation arms reduced discontinuation due to GI issues: up to 7.8% vs. higher in fixed-dose groups. A companion Phase\u202fI PK-LDI study showed vomiting rates of ~22\u201324% with no GI-driven discontinuations.<\/li>\n<\/ul>\n\n\n\n<p><strong>KOL Views<\/strong><\/p>\n\n\n\n<p>\u201cIt is encouraging that substantial weight reduction continues through week 52 without signs of plateau. This suggests that sustained, monthly dosing of MariTide could provide long\u2011term metabolic management in people with and without T2D.\u201d \u2013 <strong>Expert Opinion<\/strong><\/p>\n\n\n\n<p>\u201cThe Phase\u202fII efficacy and safety outcomes, coupled with dose\u2011escalation tolerability data, directly informed the Phase\u202fIII MARITIME protocol. Monthly or less frequent administration represents a meaningful advance in real\u2011world obesity treatment adherence.\u201d \u2013 <strong>Expert Opinion<\/strong><\/p>\n\n\n\n<p><strong>Conclusion<\/strong><\/p>\n\n\n\n<p>MariTide shows promise as a monthly (or less frequent) obesity and T2D treatment\u2014with robust, ongoing weight loss, meaningful cardiometabolic improvements, and enhanced tolerability through dose titration. The data support the design of Amgen\u2019s Phase\u202fII MARITIME studies (72-week duration, structured dose escalation) and upcoming trials in cardiovascular disease, heart failure, and sleep apnea.&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Summary Amgen\u2019s Phase\u202fII trial (NCT05669599) of MariTide (maridebart cafraglutide), a monthly peptide\u2011antibody conjugate targeting GLP\u20111 activation and GIP inhibition, demonstrated strong and ongoing weight loss\u2014including up to ~20% in people with obesity without diabetes and ~17% in those with T2D\u2014alongside cardiometabolic improvements. A lower-dose initiation approach significantly improved tolerability without affecting efficacy. These findings are [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":32695,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[17126],"tags":[22599],"industry":[17225],"therapeutic_areas":[17240],"class_list":["post-32693","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-others","tag-ada-annual-conference","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MariTide Phase II Trial | ADA 2025<\/title>\n<meta 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