CLINICAL TRIAL article
Front. Endocrinol.
Sec. Clinical Diabetes
Volume 16 - 2025 | doi: 10.3389/fendo.2025.1622526
Effect of Ebenatide on Glycemic Metabolism and Body Fat in Patients with Type 2 Diabetes Mellitus
Provisionally accepted
- 1Nanjing First Hospital, Nanjing Medical University, Nanjing, China
- 2Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
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Aim: Investigate effects of Ebenatide, a novel glucagon-like peptide-1 analogue, on glycemic control and body composition in type 2 diabetes mellitus (T2DM).Methods: This randomized, prospective, interventional study enrolled 78 subjects (76 subjects finished). Subjects were randomized to either the Ebenatide group (52 subjects, Ebenatide for 52 weeks) or the placebo group (24 subjects, placebo for 24 weeks followed by Ebenatide for 28 weeks) according to a 2:1 allocation ratio.Continuous Glucose Monitoring, body composition and biochemical parameters were assessed at baseline, Week 24 and Week 52 of treatment. Assessments included continuous glucose monitoring and body composition analysis.The Ebenatide group showed significantly lower in hemoglobin A1c (HbA1c), mean blood glucose (MBG), time above range (TAR) and standard deviation (SD), along with improvement of time in range (TIR) at Week 24 and Week 52 compared to baseline (P<0.05), with no statistical difference in time in range (TBR).The triglyceride-glucose index (TyG) decreased at Week 24 (P=0.063) and Week 52 compared with baseline (P<0.01). Compared with the placebo group, the Ebenatide group demonstrated greater reductions in HbA1c and TAR and improved TIR at Week 24 (P<0.05), but no difference at Week 52.Body composition analysis showed that the Ebenatide group had significant declines in weight, BMI, body fat and waist-to-height ratio (WHtR) at Week 24 and Week 52 compared with baseline (P<0.05).Compared with baseline, the Ebenatide group exhibited decreased blood pressure and hemoglobin levels and elevated serum amylase and lipase levels at Week 24 and Week 52 (P<0.05). Adverse events were limited to gastrointestinal reactions.Ebenatide treatment for 24 weeks obvious significantly improved HbA1c, TIR, TyG, weight and WHtR in T2DM subjects, with these benefits sustained for at least 52 weeks.
Keywords: Ebenatide, type 2 diabetes mellitus, GLP-1, Continuous glucose monitoring, body fat
Received: 03 May 2025; Accepted: 29 May 2025.
Copyright: © 2025 Xu, Kong, Liu, Xu, Liu and Ma. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Bingli Liu, Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
Jianhua Ma, Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China
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