A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity
Recruiting · NCT07160400 · Interventional (participants receive a specific treatment) · Lead sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center)
View the official record on ClinicalTrials.gov →Interventions studied
IBI3032 tabletsPlacebo
What this trial is about
This is a randomized, double-blind, placebo-controlled phase 1 clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single ascending dose of IBI3032 in healthy participants and multiple ascending doses of IBI3032 in participants with overweight or obesity. It consists of 2 parts: Part A is a single ascending dose (SAD) study in healthy participants, and Part B is a multiple ascending dose (MAD) study in participants with overweight or obesity during the 4-week treatment period.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female aged 18-65 years (inclusive) at the time of informed consent.
- Participants must understand the procedures and methods of this study, be willing to complete the study in strict accordance with the clinical study protocol, and voluntarily sign the informed consent form.
Exclusion criteria
- The investigator suspects that the participant may be allergic to any component of the study drug or GLP-1 receptor agonists, or have used GLP-1 receptor agonists within 3 months prior to screening.
- History of diabetes, or HbA1c ≥ 6.5% and fasting blood glucose \< 3.9 mmol/L or ≥ 7.0 mmol/Lat screening.
- Presence of any other abnormalities in vital signs and laboratory tests that are clinically significant as judged by the investigator at screening.
Where it is running
1 location listed.
- Zhongshan Hospital affiliated to Fudan University - Shanghai, Shanghai Municipality, China