Phase III Study of DA-302168S Tablets for Treating Overweight and Obese Adults in China

What this Trial Is About

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial to study DA-302168S tablets in overweight or obese adults in China. The study aims to evaluate the drugs effectiveness, safety, and how the body processes it. This trial plans to include about 840 participants who meet specific body weight and health criteria. Participants will be randomly assigned to one of three groups a high-dose group receiving DA-302168S starting at 2.5 mg and titrated to 20 mg, a low-dose group titrated to 10 mg, or a placebo group receiving matching tablets. All treatments are given once daily by mouth. The study includes a screening period of up to 2 weeks, a 52-week treatment period with guidance on diet and exercise, and a 2-week safety follow-up after treatment. Throughout the study, participants will attend regular visits for monitoring body weight changes, blood tests for glucose, lipids, and other health markers, and questionnaires assessing quality of life. Researchers will measure outcomes like percentage weight change and the proportion of participants achieving weight loss goals at weeks 40 and 52. Safety is monitored carefully during and after treatment, with participants involved for a total of about 56 weeks.

A Study of DA-302168S in Participants With Overweight/Obesity