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

Innovent Biologics Technology Limited (Shanghai R&D Center)80 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Part A: Healthy Part B: Overweight or Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Part A: Baseline up to Day 15

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.

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

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

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

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

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

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

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

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

Time frame: Part B: Baseline up to Day 43

Secondary Outcomes

Under the Serum Concentration-time Curve (AUC) of IBI3032

To evaluate the pharmacokinetic (PK) characteristics of a single dose of IBI3032 in healthy participants.

Time frame: Part A: Predose up to 168 hours postdose

Under the Serum Concentration-time Curve (AUC) of IBI3032