A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, IBI3032 tablets.
- Who it may be relevant to
- Registry conditions: Part A: Healthy Part B: Overweight or Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase 1 Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI3032 After a Single Ascending Dose in Healthy Participants and After Multiple Ascending Doses in Participants With Overweight or Obesity
Overview
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.
Interventions
- Drug Placebo
Single dose placebo IBI3032 administered orally - Drug IBI3032 tablets
Single dose of IBI3032 administered orally
Primary outcome measures
- Number of Participants with adverse events (AEs) [Time frame: Part A: Baseline up to Day 15]
- Number of Participants with adverse events (AEs) [Time frame: Part B: Baseline up to Day 43]
- Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug [Time frame: Part A: Baseline up to Day 15]
- Number of Participants with One Serious Adverse Event(s) Considered by the Investigator to be Related to Study Drug [Time frame: Part B: Baseline up to Day 43]
- Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [Time frame: Part A: Baseline up to Day 15]
- Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [Time frame: Part B: Baseline up to Day 43]
Secondary outcome measures (12)
- Under the Serum Concentration-time Curve (AUC) of IBI3032 [Time frame: Part A: Predose up to 168 hours postdose]
- Under the Serum Concentration-time Curve (AUC) of IBI3032 [Time frame: Part B: Predose up to 168 hours postdose]
- maximum concentration (Cmax) of IBI3032 [Time frame: Part A: Predose up to 168 hours postdose]
- maximum concentration (Cmax) of IBI3032 [Time frame: Part B: Predose up to 168 hours postdose]
- time to maximum concentration (Tmax) of IBI3032 [Time frame: Part A: Predose up to 168 hours postdose]
- time to maximum concentration (Tmax) of IBI3032 [Time frame: Part B: Predose up to 168 hours postdose]
- clearance (CL) of IBI3032 [Time frame: Part A: Predose up to 168 hours postdose]
- clearance (CL) of IBI3032 [Time frame: Part B: Predose up to 168 hours postdose]
- apparent volume of distribution (V) of IBI3032 [Time frame: Part A: Predose up to 168 hours postdose]
- apparent volume of distribution (V) of IBI3032 [Time frame: Part B: Predose up to 168 hours postdose]
- elimination half-life (T1/2) of IBI3032 [Time frame: Part A: Predose up to 168 hours postdose]
- elimination half-life (T1/2) of IBI3032 [Time frame: Part B: Predose up to 168 hours postdose]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital affiliated to Fudan University — Shanghai
Identifiers
NCT: NCT07160400 · CIBI3032A101