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.

中文翻译：

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262-OR：Pemvidutide，一种 GLP-1/胰高血糖素双受体激动剂，用于超重或肥胖受试者——一项为期 48 周、安慰剂对照、2 期 (MOMENTUM) 试验


简介和目的：Pemvidutide 是一种 GLP-1/胰高血糖素双受体激动剂，正在开发用于治疗肥胖症。方法：MOMENTUM 是一项 2 期、随机、安慰剂对照试验，受试者为超重 (BMI 27.0-29.9 kg/m2) 和至少一种肥胖相关合并症或肥胖 (BMI > 30.0 kg/m2) 的受试者，随机比例为 1:1：每周皮下注射 1:1 的培维肽（1.2、1.8、2.4 mg）或安慰剂，持续 48 周。结果：共有 391 名受试者入组，平均年龄、体重和 BMI 分别为 50 岁、105 kg 和 37 kg/m2。第 48 周时，接受 1.2 mg、1.8 mg 和 2.4 mg 剂量的培维肽治疗的受试者与安慰剂 (2.2%) 相比，平均体重减轻分别为 10.3%、11.2% 和 15.6%（与安慰剂相比，p<0.001，所有剂量，图 1），根据试验结论，2.4 mg 剂量水平下，51.8% 和 32.1% 的受试者实现了 ≥15% 和 ≥20% 的体重减轻，48% 的受试者消除了基线肥胖。基线时血脂升高的受试者在第 48 周时甘油三酯、总胆固醇和 LDL 分别降低了 55.8%、20.0% 和 21.8%。大多数不良事件为轻度至中度，只有 1 例与药物相关的 SAE；血糖控制（葡萄糖、HbA1c）得以维持，心率增加幅度最小。结论：派维度肽安全且耐受性良好，在 48 周的治疗过程中可显着降低体重和血脂。披露 L. Aronne：顾问小组；诺和诺德。顾问;诺和诺德。顾问小组；礼来糖尿病 (Lilly Diabetes)，Altimmune Inc. 顾问；莉莉糖尿病。顾问小组；辉瑞公司顾问；联合健康集团。顾问小组；勃林格殷格翰。董事会成员;阿斯利康。顾问小组；安进公司 M. Harris：员工； Altimmune Inc. 硕士罗伯茨：员工； Altimmune Inc. J.J. Suschak：员工； Altimmune Inc. S. Tomah：员工； Altimmune Inc. J. Kasper：员工； Altimmune Inc. L. He：没有。杨俊杰：没有。 J.P. Frias：研究支持； Akero Therapeutics 有限公司顾问； Akero Therapeutics, Inc. 研究支持； Altimmune 公司顾问； Altimmune Inc. 研究支持；勃林格殷格翰。顾问;勃林格殷格翰。研究支持； 89bio, Inc. 顾问； 89bio, Inc. 研究支持；礼来公司。顾问小组；礼来公司。议长局；礼来公司。研究支持；默克公司顾问；默克公司研究支持；诺华制药公司。顾问;诺华制药公司、诺和诺德。董事会成员;诺和诺德。研究支持；诺和诺德、辉瑞公司顾问；辉瑞公司顾问小组；赛诺菲。议长局；赛诺菲。研究支持；赛诺菲。股票/股东； Biomea Fusion, Inc. 员工； Biomea Fusion, Inc. S.K.布朗：雇员；阿尔提免疫公司