Efficacy and Safety of Glp-1 Analog Ecnoglutide in Adults With Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

Authors

Dalong Zhu
Weimin Wang
Guoyu Tong
Guoqing Ma
Jianhua Ma
Jie Han
Xin Zhang
Yang Liu
Shenglian Gan
Hong Qin
Qing Zheng
Jing Ning
Zhiyi Zhu
Mengying Guo
Yue Bu
Yao Li
Catherine L Jones
Martijn Fenaux
Mohammed K Junaidi
Susan Xu
Hai Pan

Publication Date

9-27-2024

Journal

Nature Communications

Abstract

Glucagon-like peptide-1 (GLP-1) analogs are important therapeutics for type 2 diabetes and obesity. Ecnoglutide (XW003) is a novel, long-acting GLP-1 analog. We conducted a Phase 2, randomized, double-blind, placebo-controlled study enrolling 145 adults with T2DM. Participants were randomized to 0.4, 0.8, or 1.2 mg ecnoglutide or placebo as once-weekly injections for 20 weeks. The primary objective was to evaluate the efficacy of ecnoglutide, as measured by HbA1c change from baseline at Week 20. Secondary endpoints included body weight, glucose and lipid parameters, as well as safety. We show that, at end of treatment, the 0.4, 0.8, and 1.2 mg groups had statistically significant HbA1c reductions from baseline of -1.81%, -1.90%, and -2.39%, respectively, compared to -0.55% for placebo (P < 0.0001). At end of treatment, 71.9% of the 1.2 mg group had HbA1c ≤ 6.5% versus 9.1% on placebo, and 33.3% had body weight reductions ≥5% versus 3.0% for placebo. Ecnoglutide was generally safe and well tolerated. China Drug Trials Registry CTR20211014.

Keywords

Humans, Diabetes Mellitus, Type 2, Middle Aged, Male, Female, Double-Blind Method, Glucagon-Like Peptide 1, Glycated Hemoglobin, Adult, Blood Glucose, Hypoglycemic Agents, Aged, Treatment Outcome, Body Weight, Type 2 diabetes, Obesity, Drug development

Comments

Supplementary Materials

Data Availability Statement

PMID: 39333121