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.
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.
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.
Sequential
Placebo
DrugSingle dose placebo IBI3032 administered orally
IBI3032 tablets
DrugSingle dose of IBI3032 administered orally
Number of Participants with adverse events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Number of Participants with adverse events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.
Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.
Under the Serum Concentration-time Curve (AUC) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
Under the Serum Concentration-time Curve (AUC) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
maximum concentration (Cmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.
maximum concentration (Cmax) of IBI3032
To evaluate the pharmacokinetic (PK) characteristics of multiple doses of IBI3032 in participants with overweight or obesity.
Click on the lead sponsor to view all of their trials.
