IBI3032 in healthy adults and adults with overweight or obesity (China)

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

We will test single and multiple doses of IBI3032 to see if they are safe and how the body handles them in healthy adults and adults with overweight or obesity in China.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Innovent Biologics Technology Limited (Shanghai R&D Center) (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07160400 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 1 study with two parts: Part A is a single ascending dose (SAD) in healthy participants and Part B is a multiple ascending dose (MAD) over a 4-week treatment period in participants with overweight or obesity. The trial compares IBI3032 tablets to matching placebo and collects safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) data. Participants are assigned to dose cohorts and monitored with clinical exams, laboratory tests, and PK/PD sampling. The main objective is to characterize dose-related safety and PK/PD to guide further development.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–65 who can give informed consent and complete study visits, either healthy for the single-dose part or meeting criteria for overweight or obesity for the multiple-dose part, without diabetes or recent GLP‑1 agonist use.

Not a fit: People with diabetes (or HbA1c ≥ 6.5%), recent use of GLP‑1 receptor agonists, known allergy to GLP‑1 drugs, clinically significant abnormal labs or vital signs, or those outside the 18–65 age range are unlikely to be eligible or to benefit from participation.

Why it matters

Potential benefit: If successful, IBI3032 could offer a new oral option with a favorable safety and pharmacokinetic profile for managing overweight or obesity.

How similar studies have performed: Other GLP‑1 receptor agonists have demonstrated clear benefits for weight loss and metabolic control, but IBI3032 is a new oral candidate and this Phase 1 trial is an early test of its safety and PK/PD.

Eligibility criteria

Inclusion Criteria:

1. Male or female aged 18-65 years (inclusive) at the time of informed consent.
2. 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:

1. 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.
2. History of diabetes, or HbA1c ≥ 6.5% and fasting blood glucose \< 3.9 mmol/L or ≥ 7.0 mmol/Lat screening.
3. Presence of any other abnormalities in vital signs and laboratory tests that are clinically significant as judged by the investigator at screening.

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital affiliated to Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Dee Li

Conditions Part A: Healthy Part B: Overweight or Obesity