{"id":69727,"date":"2025-08-18T12:43:07","date_gmt":"2025-08-18T16:43:07","guid":{"rendered":"https:\/\/www.med.unc.edu\/medicine\/?p=69727"},"modified":"2025-08-18T12:43:07","modified_gmt":"2025-08-18T16:43:07","slug":"unc-joins-phase-3-catt1-trial-investigating-cadisegliatin-as-adjunctive-therapy-for-type-1-diabetes","status":"publish","type":"post","link":"https:\/\/www.med.unc.edu\/medicine\/news\/unc-joins-phase-3-catt1-trial-investigating-cadisegliatin-as-adjunctive-therapy-for-type-1-diabetes\/","title":{"rendered":"UNC Joins Phase 3 CATT1 Trial Investigating Cadisegliatin as Adjunctive Therapy for Type 1 Diabetes"},"content":{"rendered":"<p>The University of North Carolina will serve as a study site for the vTv Therapeutics Inc. CATT1 Phase 3 trial \u00a0investigating <em>cadisegliatin<\/em> as an adjunctive treatment to insulin in adults with type 1 diabetes (T1D). <em>Cadisegliatin <\/em>is a potential first-in-class, oral, liver-selective glucokinase activator for T1D that has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) and has been well-tolerated in over 500 subjects to date with up to six months of treatment.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\" wp-image-60388 alignright\" src=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2015\/07\/Klara-Klein.jpeg\" alt=\"\" width=\"200\" height=\"267\" srcset=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2015\/07\/Klara-Klein.jpeg 656w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2015\/07\/Klara-Klein-225x300.jpeg 225w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2015\/07\/Klara-Klein-600x799.jpeg 600w, https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2015\/07\/Klara-Klein-301x401.jpeg 301w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/>\u201cAlthough there have been major advances in medical devices for the treatment of type 1 diabetes, there is a huge unmet need to identify therapies that improve glycemia without increasing the risk of ketosis or hypoglycemia,\u201d said diabetes expert, Klara Klein, MD, PhD, who is Assistant Professor of Medicine in the UNC Division of Endocrinology and Metabolism. \u201cPeople with type 1 diabetes continue to walk a tightrope between hyper- and hypoglycemia. There&#8217;s real potential for glucokinase activators not only to improve glycemia overall but to do so while providing some protection against hypoglycemia and, potentially, diabetic ketoacidosis, which could ease some of the mental burden of type 1 diabetes care.\u201d<\/p>\n<p>The Phase 3 CATT1 trial (<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=X4_pZdUy0PB5io9lJnG-mKYRJWNYlqNScT2STHOt6FRijFgUEncHMuxlA6I2IofKlSTNeiqYfocIo3yjbGLuJ2-cVNl49qbm96n7CDNI17vaw-0uzU6-A-QvStvJ6vYgYd61ZJ6NLu4Q_pXK_VJJtg==\" target=\"_blank\" rel=\"nofollow noopener\">NCT06334133<\/a>) is being conducted at up to 25 sites in the U.S. Dr. Klein is the Principal Investigator of the UNC study site. Recruitment is ongoing, and the trial is expected to enroll approximately 150 participants. The trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of <em>cadisegliatin<\/em> over six months in adults 18 years or older diagnosed with T1D. Two different dose regimens (800 mg once or twice daily) of orally administered <em>cadisegliatin<\/em> versus placebo will be assessed in participants currently being treated with multiple daily insulin injections or continuous subcutaneous insulin infusion.<\/p>\n<p><a href=\"https:\/\/ir.vtvtherapeutics.com\/news-releases\/news-release-details\/vtv-therapeutics-announces-first-study-participant-randomized\">Read more about the study on vTv Therapeutics Inc.\u00a0<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The University of North Carolina will serve as a study site for the vTv Therapeutics Inc. CATT1 Phase 3 trial \u00a0investigating cadisegliatin as an adjunctive treatment to insulin in adults with type 1 diabetes (T1D). Cadisegliatin is a potential first-in-class, oral, liver-selective glucokinase activator for T1D that has been granted Breakthrough Therapy designation by the &hellip; <a href=\"https:\/\/www.med.unc.edu\/medicine\/news\/unc-joins-phase-3-catt1-trial-investigating-cadisegliatin-as-adjunctive-therapy-for-type-1-diabetes\/\" aria-label=\"Read more about UNC Joins Phase 3 CATT1 Trial Investigating Cadisegliatin as Adjunctive Therapy for Type 1 Diabetes\">Read more<\/a><\/p>\n","protected":false},"author":112673,"featured_media":3663,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","footnotes":"","_links_to":"","_links_to_target":""},"categories":[2,583],"tags":[686],"class_list":["post-69727","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","category-research-news","tag-686","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>UNC Joins Phase 3 CATT1 Trial Investigating Cadisegliatin as Adjunctive Therapy for Type 1 Diabetes | Department of Medicine<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/medicine\/news\/unc-joins-phase-3-catt1-trial-investigating-cadisegliatin-as-adjunctive-therapy-for-type-1-diabetes\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UNC Joins Phase 3 CATT1 Trial Investigating Cadisegliatin as Adjunctive Therapy for Type 1 Diabetes | Department of Medicine\" \/>\n<meta property=\"og:description\" content=\"The University of North Carolina will serve as a study site for the vTv Therapeutics Inc. 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Cadisegliatin is a potential first-in-class, oral, liver-selective glucokinase activator for T1D that has been granted Breakthrough Therapy designation by the &hellip; Read more\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.med.unc.edu\/medicine\/news\/unc-joins-phase-3-catt1-trial-investigating-cadisegliatin-as-adjunctive-therapy-for-type-1-diabetes\/\" \/>\n<meta property=\"og:site_name\" content=\"Department of Medicine\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/UNCDeptMedicine\" \/>\n<meta property=\"article:published_time\" content=\"2025-08-18T16:43:07+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2018\/12\/macnider.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"580\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Morgan Duerden\" 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