Participants receiving experienced body weight reductions ranging from -6.3 kg to -7.2 kg compared to placebo over 20 weeks.
All doses of efpeglenatide resulted in significant body weight loss compared to placebo (P < 0.0001).
Higher proportions of participants treated with efpeglenatide achieved weight loss of ≥5% or ≥10% compared to those on placebo (P < 0.01).
Efpeglenatide improved glycemic levels, reducing fasting plasma glucose and glycated hemoglobin more effectively than placebo.
Lipid profiles, including cholesterol and triglycerides, showed significant improvement with efpeglenatide treatment compared to placebo.
Gastrointestinal effects were the most frequently reported adverse events associated with efpeglenatide, with discontinuation rates due to adverse events ranging from 5% to 19%.
Simplified
AIM: To evaluate the safety of , a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), and its effects on body weight management in adults without diabetes.
MATERIALS AND METHODS: In this phase II, randomized, placebo-controlled, double-blind trial, participants with a (BMI) ≥30 kg/mor ≥27 kg/mwith comorbidity were randomized 1:1:1:1:1 to efpeglenatide (4 mg once weekly, 6 mg once weekly, 6 mg once every 2 wk, or 8 mg once every 2 wk; n = 237) or placebo (n = 60) in combination with a hypocaloric diet. The primary endpoint was body weight change from baseline after 20 wk of treatment, assessed using a mixed-effect model with repeated measures with an unstructured covariance matrix over all post-screening visits; treatment comparisons were based on least squares mean estimates. 2 2
RESULTS: Over 20 wk, all doses of efpeglenatide significantly reduced body weight from baseline versus placebo (P < 0.0001), with placebo-adjusted reductions ranging between -6.3 kg (6 mg once every 2 wk) and -7.2 kg (6 mg once weekly). Greater proportions of efpeglenatide-treated participants had body weight loss of ≥5% or ≥10% versus placebo (P < 0.01, all comparisons). Efpeglenatide led to significant improvements in glycaemic variables (fasting plasma glucose and glycated haemoglobin) and lipid profiles (cholesterol, triglycerides) versus placebo. Rates of study discontinuations as a result of adverse events ranged from 5% to 19% with efpeglenatide. Gastrointestinal effects were the most common treatment-emergent adverse events.
CONCLUSIONS: Efpeglenatide once weekly and once every 2 wk led to significant body weight reduction and improved glycaemic and lipid variables versus placebo. It was also well tolerated for weight management in adults without diabetes.
Key numbers
-7.2 kg
Weight Reduction
Difference in body weight change from baseline vs. placebo for 6 mg once weekly.
53.4%
Proportion Losing ≥5% Body Weight
Percentage of participants with ≥5% weight loss at week 21 compared to placebo.
27.1%
Proportion Losing ≥10% Body Weight
Percentage of participants with ≥10% weight loss at week 21 compared to placebo.
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R.E.P. has served as a consultant for AstraZeneca, Eli Lilly, Janssen Pharmaceuticals, Merck, Novo Nordisk, Pfizer and Sanofi, has received grants and research support from Eli Lilly, Janssen Pharmaceuticals, Lexicon, Ligand, Merck, Novo Nordisk and Sanofi‐Aventis US, and has received honoraria from Novo Nordisk; honoraria and fees for these activities are directed to a non‐profit organization. J.K. is an employee of Hanmi Pharmaceutical. M.E.T. is a consultant of ProSciento and a shareholder of Eli Lilly, and has received consulting fees from AstraZeneca, Intarcia and Servier. M.H. is an employee and shareholder of ProSciento. O.H. is an employee of Hanmi Pharmaceutical. J.S. and C.H.S. are employees and shareholders of Sanofi. S.J. has served as a consultant for AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Eli Lilly, Merck, Novo Nordisk, Orexigen, Roche and Servier, and has received honoraria from Abbott, AstraZeneca, Bayer, Berlin Chemie, Boehringer Ingelheim, Johnson & Johnson, Eli Lilly, Merck, Novartis, Novo Nordisk, Orexigen, Roche, Sanofi‐Aventis and Servier. K.‐H.Y. has received honoraria from AstraZeneca, Boehringer Ingelheim, Eli Lilly, Hanmi Pharmaceutical, Merck, Novo Nordisk, Sanofi and Takeda, and research support from AstraZeneca and Takeda.
