Phase III Study of Weekly Enicepatide Injections for Adults with Obesity or Overweight, With or Without Type 2 Diabetes

What this Trial Is About

Researchers are studying enicepatide, a dual GLP-1GIP receptor agonist, to evaluate its safety and effectiveness for chronic weight management. This study focuses on adults with obesity or overweight who either have or do not have type 2 diabetes mellitus T2DM. The goal is to understand how enicepatide can support weight loss alongside diet and physical activity. Participants will be randomly assigned to receive one of three doses of enicepatide or a matching placebo. The medication is given as a weekly subcutaneous injection. All participants will follow a reduced-calorie diet and increased physical activity during the study. Treatment will continue for 52 weeks, with assessments throughout the period. During the study, participants will undergo various evaluations including body weight, waist circumference, blood glucose, insulin levels, cholesterol, blood pressure, and quality of life questionnaires. Researchers will monitor changes from baseline to week 52 and track safety through adverse event reporting. The total participation duration extends to approximately one year with regular visits for treatment and assessments.

A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes