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

Innovent Biologics Technology Limited (Shanghai R&D Center)

Status and phase: Enrolling; Phase 1

Conditions: Part A: Healthy Part B: Overweight or Obesity

Treatments: Drug: Placebo; Drug: IBI3032 tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT07160400

CIBI3032A101

Details and patient eligibility

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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104 participants in 4 patient groups, including a placebo group

Single dose of IBI3032 administered orally.

Experimental group

Description:

Part A

Treatment:

Drug: IBI3032 tablets

Single dose of placebo administered orally.

Placebo Comparator group

Description:

Part A

Treatment:

Drug: Placebo

Multiple doses of IBI3032 administered orally.

Experimental group

Description:

Part B

Treatment:

Drug: IBI3032 tablets

Multiple doses of placebo administered orally.

Placebo Comparator group

Description:

Part B

Treatment:

Drug: Placebo