A Study of IBI3032 in Chinese Healthy Participants and Participants With Overweight or Obesity

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorInnovent Biologics Technology Limited (Shanghai R&D Center)

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Placebo
  • IBI3032 tablets

Treatment groups

104 Participants
are divided into 4 treatment groups