Phase II Study to Evaluate the Safety, Effectiveness, and Drug Behavior of Efsubaglutide Alfa Injection in Adults With Overweight or Obesity

What this Trial Is About

Researchers are evaluating the drug Efsubaglutide Alfa in adults aged 18 to 75 who are overweight or obese. This phase 2, multicenter, double-blind, randomized, placebo-controlled study aims to assess the drugs effectiveness, safety, how the body processes it, and immune response in people with a body mass index BMI between 27 and 30 with at least one related health condition or a BMI of 30 or above with or without other health issues. The study includes a 2-week screening period, a 22-week treatment phase, and a 4-week follow-up after treatment ends. Participants will receive Efsubaglutide Alfa or a placebo through weekly injections. The drug dose starts at 1 mg and is increased every two weeks through a series of steps until reaching a target dose that varies by study group, ranging from 20 mg to 80 mg. Some groups receive the highest dose every one or two weeks, and the total treatment lasts for 22 weeks. The study compares multiple dosing schedules to evaluate effects across different doses and frequencies. During the trial, participants will attend scheduled visits for weight and body measurements, blood pressure, and blood tests including blood sugar and cholesterol levels. Body composition will be measured using DEXA scans. Safety will be monitored throughout by tracking side effects and mental health using questionnaires. Blood samples will also be collected to measure drug levels and immune response. Overall, the study helps understand how the drug affects body weight and other health markers in people with overweight or obesity over about 28 weeks from screening to follow-up.

The Efficacy and Safety of Efsubaglutide Alfa in Overweight/Obesity（SPARKLE）