Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial
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.
Authors
- Hongbo Pan (ORCID: https://orcid.org/0000-0001-5047-0463)
- MOHAMMED K. JUNAIDI
- Shenglian Gan (ORCID: https://orcid.org/0000-0003-3005-183X)
- Mengying Guo
- Martijn Fenaux
- Dalong Zhu (ORCID: https://orcid.org/0000-0002-1064-1261)
- Weimin Wang (ORCID: https://orcid.org/0000-0002-9852-1589)
- Xin Zhang (ORCID: https://orcid.org/0000-0003-0394-7972)
- Jianhua Ma (ORCID: https://orcid.org/0000-0003-4497-0407)
- Yang Liu (ORCID: https://orcid.org/0000-0002-4989-2404)
- Yao Li (ORCID: https://orcid.org/0000-0003-4330-6440)
- Guoqing Ma
- Zhiyi Zhu
- Hong Qin (ORCID: https://orcid.org/0000-0002-1927-0081)
- Jing Ning (ORCID: https://orcid.org/0009-0005-3785-6923)
- Catherine L. Jones (ORCID: https://orcid.org/0009-0005-1432-9039)
- Jie Han
- Qing Zheng (ORCID: https://orcid.org/0000-0002-4136-392X)
- Susan H. Xu
- Guoyu Tong
- Yue Bu
Institutions
- National Federation of the Blind (US)
- Harbin Medical University (CN)
- Heilongjiang University of Chinese Medicine (CN)
- Flower Hospital (US)
- Daqing City People's Hospital (CN)
- National Clinical Research Center for Digestive Diseases (CN)
- First Affiliated Hospital of Heilongjiang University of Chinese Medicine (CN)
- Nanjing Drum Tower Hospital (CN)
- BD Biosciences (United States) (US)
- The First People's Hospital of Changde (CN)
- China National Petroleum Corporation (China) (CN)
Publication Details
- Journal
- Nature Communications
- Published
- 2024-09-27
- DOI
- https://doi.org/10.1038/s41467-024-52353-y
- Citations
- 21
- Primary Topic
- Diabetes Treatment and Management
- Type
- article
- Field-Weighted Citation Impact
- 7.51
Funders
- American Diabetes Association