53-OR: Efficacy and Safety of Coadministered s.c. Semaglutide and s.c. Cagrilintide in Type 2 Diabetes

Abstract

Combining sema (semaglutide 2.4 mg) and amylin analog cagri (cagrilintide 2.4 mg) has weight loss benefits, but the impact on HbA1c is unknown. This study is the first to assess the efficacy and safety of CagriSema (co-administered) vs sema or cagri alone in participants (pts) with T2D. In this phase 2 (NCT04982575), multicenter, double-blind trial, adults with T2D (HbA1c 7.5-10.0%) and BMI ≥27 kg/m2 on metformin ± SGLT2i, were randomized to once-weekly s.c. CagriSema, sema, or cagri for 32 weeks (all escalated over 16 weeks to 2.4 mg). The primary endpoint was change from baseline in HbA1c; key secondary endpoints were body weight and safety. Of the 92 pts randomized (64% male; mean age 58 years and T2D duration 8.7 years), those receiving CagriSema had significantly greater reductions in HbA1c (vs cagri) and body weight (vs sema and cagri) at week 32 (Figure). The proportion of pts achieving HbA1c <7.0% and ≤6.5%, were 89% and 75% for CagriSema, 69% and 48% for sema, and 33% and 17% for cagri at week 32. GI AEs were most common (58% for CagriSema, 32% for sema, and 33% for cagri), were mainly mild/moderate, occurred during dose escalation, and lead to treatment discontinuation in 0%, 3%, and 0% of pts with CagriSema, sema, and cagri, respectively; no level 2 or 3 hypoglycemia was reported. CagriSema improved glycemic control and led to significant weight loss vs both sema or cagri, and was well tolerated with no new safety signals. Disclosure J.P.Frias: Advisory Panel; Becton, Dickinson and Company, Pfizer Inc., Sanofi, Consultant; Akero Therapeutics, Inc., 89bio, Inc., Aimmune, Boehringer Ingelheim Inc., Eli Lilly and Company, Carmot Therapeutics, Inc., Echosens, Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Pfizer Inc., Sanofi, Employee; Ionis Pharmaceuticals, Research Support; Akero Therapeutics, Inc., 89bio, Inc., Altimmune, Axcella Health Inc., Boehringer Ingelheim Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Carmot Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Metacrine, Inc., Novo Nordisk, Oramed Pharmaceuticals, Novartis, Pfizer Inc., Sanofi, Speaker's Bureau; Eli Lilly and Company, Sanofi. S.Deenadayalan: Employee; Novo Nordisk A/S. L.Erichsen: None. F.K.Knop: Advisory Panel; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Consultant; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Research Support; Novo Nordisk, Zealand Pharma A/S, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi, Lundbeck. I.Lingvay: Advisory Panel; Novo Nordisk A/S, Lilly Diabetes, Boehringer-Ingelheim, Sanofi, Consultant; Carmot Therapeutics, Inc., Merck Sharp & Dohme Corp., Janssen Scientific Affairs, LLC, Pfizer Inc., Intercept, Intarcia, Valeritas, TargetRWE, Shionogi, Zealand Pharma, Structure, Bayer, Research Support; Novo Nordisk A/S, Boehringer-Ingelheim. S.Macura: Employee; Novo Nordisk A/S, Stock/Shareholder; Novo Nordisk A/S. C.Mathieu: Advisory Panel; Novo Nordisk A/S, Boehringer Ingelheim Inc., Eli Lilly and Company, Medtronic, Vertex Pharmaceuticals Incorporated, Roche Diabetes Care, Imcyse, Speaker's Bureau; Novo Nordisk A/S, AstraZeneca, Boehringer Ingelheim Inc., Eli Lilly and Company, Medtronic, Vertex Pharmaceuticals Incorporated. S.D.Pedersen: Advisory Panel; Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim (Canada) Ltd., AstraZeneca, HLS Therapeutics Inc., Bayer Inc., Viatris Inc., Bausch + Lomb, Research Support; Eli Lilly and Company, Novo Nordisk, AstraZeneca, Applied Therapeutics Inc., Speaker's Bureau; Abbott Diabetes, Eli Lilly and Company, Novo Nordisk, Boehringer Ingelheim (Canada) Ltd., AstraZeneca, Medtronic, Pfizer Inc., HLS Therapeutics Inc., Bayer Inc., Bausch + Lomb. M.J.Davies: Advisory Panel; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Lexicon Pharmaceuticals, Inc., Pfizer Inc., Medtronic, ShouTi Pharma Inc., Consultant; Lilly, Boehringer-Ingelheim, Novo Nordisk, Sanofi, Research Support; AstraZeneca, Novo Nordisk, Sanofi-Aventis U.S., Boehringer-Ingelheim, Janssen Pharmaceuticals, Inc., Speaker's Bureau; Lilly, Boehringer-Ingelheim, Novo Nordisk, AstraZeneca, Napp Pharmaceuticals Limited, Novartis, Sanofi. Funding Novo Nordisk A/S