Clinical trial

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

Recruiting now · Phase 1 · 1 countries · Registry ID NCT07160400

Recruiting nowPhase 1Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionPart A: Healthy Part B: Overweight or Obesity

Full registry 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.

Treatments and study arms

Placebo

Drug

Single dose placebo IBI3032 administered orally

IBI3032 tablets

Drug

Single dose of IBI3032 administered orally

Primary outcomes

Number of Participants with adverse events (AEs)Part A: Baseline up to Day 15

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)Part B: Baseline up to Day 43

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 DrugPart A: Baseline up to Day 15

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 DrugPart B: Baseline up to Day 43

A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module.

Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study DrugPart A: Baseline up to Day 15

A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Number of Participants with More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study DrugPart B: Baseline up to Day 43

A summary of other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Zhongshan Hospital affiliated to Fudan University🇨🇳 Shanghai, Shanghai Municipality, China

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Xuening LiContact

Email · Call 021-31587862

Xiaoying LiContact

Email · Call 021-31023402

Xiaoying LiPrincipal Investigator