54-OR: Effect of Coadministered s.c. Semaglutide and s.c. Cagrilintide on Glycemic Levels Measured by CGM

Abstract

Continuous glucose monitoring (CGM) offers insight into glycemic levels beyond the conventional measurement of HbA1c. This phase 2, multicenter, 32-week, double-blind trial (NCT04982575) compared the effects of CagriSema (co-administered semaglutide [sema] 2.4 mg and cagrilintide [cagri] 2.4 mg) vs sema (2.4 mg) or cagri (2.4 mg) alone, all as once-weekly subcutaneous injection, on CGM parameters (secondary endpoints). In total, 92 adult participants with T2D (HbA1c 7.5-10.0%), on metformin ± SGLT2i, and BMI ≥27 kg/m2 were randomized. Time in range (70-180 mg/dL) increased in all groups, reaching 88.9% with CagriSema at week 32 (Figure). Time in tight range (70-140 mg/dL; post-hoc analysis) increased from 16.0%, 8.8%, and 26.2% at baseline to 66.4%, 50.0%, and 36.7% at week 32 for CagriSema, sema, and cagri, respectively, with 0.8% or less in time below range for all groups. Mean glucose (measured by CGM) decreased from baseline to week 32 (CagriSema, -63.9; sema, -43.6; cagri, -23.4 mg/dL; estimated treatment difference [95% CI]: CagriSema vs sema, -20.2 [-39.8, -0.7; p=0.04], and CagriSema vs cagri, -40.5 [-59.4, -21.6; p<0.0001] mg/dL). Time in range with CagriSema reached nearly 90% at week 32, with little time below range in the first trial of CagriSema in people with T2D. Furthermore, CagriSema led to a greater reduction in mean glucose vs both sema or cagri alone. Disclosure 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.Deenadayalan: Employee; Novo Nordisk A/S. L.Erichsen: None. 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. 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. E.W.Lehmann: Employee; Novo Nordisk A/S. 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