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

• Published in: Diabetes (New York, N.Y.) Vol. 73; no. Supplement_1; p. 1
• Main Authors: ARONNE, LOUIS, SCOTT HARRIS, M., ROBERTS, M S., SUSCHAK, JOHN J., TOMAH, SHAHEEN, KASPER, JONATHAN, HE, LIANG, YANG, JAY, FRIAS, JUAN P., BROWNE, SARAH K.
• Format: Journal Article
• Language: English
• Published: New York American Diabetes Association 23.06.2024
• Subjects: Agonists; Body weight; Body weight loss; Cholesterol; Comorbidity; GLP-1 receptor agonists; Glucagon; Heart rate; Lipids; Low density lipoprotein; Obesity; Overweight; Placebos; Serum lipids; Triglycerides; Weight control
• ISSN: 0012-1797; 1939-327X
• DOI: 10.2337/db24-262-OR

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.