Study Evaluating Safety and Effects of IBI3046 in Chinese Adults With Overweight or Obesity Using Randomized, Double-Blind, Placebo-Controlled Methods

What This Trial Is About

Researchers are studying IBI3046 to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in Chinese adults who are overweight or obese. This research includes four parts single ascending dose SAD, multiple ascending dose MAD, administration of IBI3046 after stopping mazdutide, and use of IBI3046 combined with mazdutide. The study is a randomized, double-blind, placebo-controlled phase 1 trial focused on treatment. Participants receive different doses of IBI3046 or matching placebo in various cohorts across the study parts. In the first part SAD, single doses of IBI3046 or placebo are given. The second part MAD involves multiple repeated doses. In the combination phases, participants receive an active reference drug mazdutide with either IBI3046 or placebo administered at specific times to assess interactions. The study monitors safety, how the drug is processed by the body, and its effects. Participants will be monitored closely throughout the study with assessments including physical exams, blood pressure measurements, ECGs, and laboratory tests. Researchers will measure adverse events, changes in blood pressure, drug concentration in blood and urine, and body weight changes. The study includes follow-up periods up to day 169 for SAD and day 225 for MAD to observe safety and response. Total participation time varies by study part and dose cohort.

A Study of IBI3046 in Participants With Overweight or Obesity