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Diabetes Obes Metab. 2019 Jul 2. doi: 10.1111/dom.13824. [Epub ahead of print]

Body weight management and safety with efpeglenatide in adults without diabetes: A phase II randomized study.

Author information

1
Translational Research Institute for Metabolism and Diabetes, AdventHealth, Orlando, Florida.
2
Clinical Research and Development, Hanmi Pharmaceutical Co., Ltd, Seoul, South Korea.
3
Clinical and Regulatory Development, ProSciento, Chula Vista, California.
4
ProSciento, Chula Vista, California.
5
Department of Biometrics, Hanmi Pharmaceutical Co., Ltd, Seoul, South Korea.
6
Department of Biostatistics, Sanofi Canada, Laval, Quebec, Canada.
7
Medical Affairs, Sanofi, Bridgewater, New Jersey.
8
Praxis für Prävention und Therapie, Villingen-Schwenningen, Germany.
9
Endocrinology and Metabolism, Catholic University of Korea, Seoul, South Korea.

Abstract

AIM:

To evaluate the safety of efpeglenatide, 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 body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 with 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.

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.

KEYWORDS:

GLP-1; clinical trial; drug development; glycaemic control; obesity therapy; weight control

PMID:
31264757
DOI:
10.1111/dom.13824

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