262-OR: Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, in Subjects with Overweight or Obesity—A 48-Week, Placebo-Controlled, Phase 2 (MOMENTUM) Trial

Abstract

Introduction & Objective: Pemvidutide is a GLP-1/glucagon dual receptor agonist in development for treatment of obesity. Methods: MOMENTUM was a Phase 2, randomized, placebo-controlled trial of subjects with overweight (BMI 27.0-29.9 kg/m2) and at least one obesity-related comorbidity or obesity (BMI >30.0 kg/m2) randomized 1:1:1:1 to pemvidutide (1.2, 1.8, 2.4 mg) or placebo administered subcutaneously weekly for 48 weeks. Results: A total of 391 subjects with mean age, body weight, and BMI of 50 yrs, 105 kg, and 37 kg/m2 were enrolled. At week 48, subjects receiving pemvidutide achieved mean weight losses of 10.3%, 11.2%, and 15.6% at the 1.2 mg, 1.8 mg, and 2.4 mg doses vs. placebo (2.2%), respectively (p<0.001 vs. placebo, all doses, Figure 1), with 51.8% and 32.1% of subjects at the 2.4 mg dose level achieving ≥15% and ≥20% weight loss and 48% of subjects having resolution of baseline obesity by trial conclusion. Subjects with elevated serum lipids at baseline had reductions of up to 55.8%, 20.0%, and 21.8% in triglycerides, total cholesterol and LDL at week 48. Most adverse events were mild to moderate with only 1 drug-related SAE; glycemic control (glucose, HbA1c) was maintained with minimal increases in heart rate. Conclusion: Pemvidutide was safe and well-tolerated and significantly reduced body weight and serum lipids over 48 weeks of treatment. Disclosure L. Aronne: Advisory Panel; Novo Nordisk. Consultant; Novo Nordisk. Advisory Panel; Lilly Diabetes, Altimmune Inc. Consultant; Lilly Diabetes. Advisory Panel; Pfizer Inc. Consultant; UnitedHealth Group. Advisory Panel; Boehringer-Ingelheim. Board Member; AstraZeneca. Advisory Panel; Amgen Inc. M. Harris: Employee; Altimmune Inc. M.S. Roberts: Employee; Altimmune Inc. J.J. Suschak: Employee; Altimmune Inc. S. Tomah: Employee; Altimmune Inc. J. Kasper: Employee; Altimmune Inc. L. He: None. J. Yang: None. J.P. Frias: Research Support; Akero Therapeutics, Inc. Consultant; Akero Therapeutics, Inc. Research Support; Altimmune Inc. Consultant; Altimmune Inc. Research Support; Boehringer-Ingelheim. Consultant; Boehringer-Ingelheim. Research Support; 89bio, Inc. Consultant; 89bio, Inc. Research Support; Eli Lilly and Company. Advisory Panel; Eli Lilly and Company. Speaker's Bureau; Eli Lilly and Company. Research Support; Merck & Co., Inc. Consultant; Merck & Co., Inc. Research Support; Novartis Pharmaceuticals Corporation. Consultant; Novartis Pharmaceuticals Corporation, Novo Nordisk. Board Member; Novo Nordisk. Research Support; Novo Nordisk, Pfizer Inc. Consultant; Pfizer Inc. Advisory Panel; Sanofi. Speaker's Bureau; Sanofi. Research Support; Sanofi. Stock/Shareholder; Biomea Fusion, Inc. Employee; Biomea Fusion, Inc. S.K. Browne: Employee; Altimmune Inc.