A Study of IBI3032 in Chinese Participants With Overweight or Obesity

Innovent Biologics Technology Limited (Shanghai R&D Center)

Status and phase: Active, not recruiting; Phase 1

Conditions: Overweight or Obesity

Treatments: Drug: IBI3032; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07170319

CIBI3032T002

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 multiple ascending doses of IBI3032 in participants with overweight or obesity. It is a multiple ascending dose study in participants with overweight or obesity during the 4-week treatment period.

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or females, as determined by medical history
• Have safety laboratory results within normal reference ranges

Exclusion criteria

• Have known allergies toIBI3032， glucagon-like peptide-1 (GLP-1) analogs, related compounds
• Abnormal electrocardiogram (ECG) at screening
• Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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79 participants in 10 patient groups, including a placebo group

Multiple ascending dose5 of IBI3032 administered orally.

Experimental group

Description:

Cohort 5 IBI3032

Treatment:

Drug: IBI3032

Multiple ascending dose1 of placebo administered orally.

Placebo Comparator group

Description:

Cohort 1 placebo

Treatment:

Drug: placebo

Multiple ascending dose4 of placebo administered orally.

Placebo Comparator group

Description:

Cohort 4 placebo

Treatment:

Drug: placebo

Multiple ascending dose3 of IBI3032 administered orally.

Experimental group

Description:

Cohort 3 IBI3032

Treatment:

Drug: IBI3032

Multiple ascending dose4 of IBI3032 administered orally.

Experimental group

Description:

Cohort 4 IBI3032

Treatment:

Drug: IBI3032

Multiple ascending dose2 of IBI3032 administered orally.

Experimental group

Description:

Cohort 2 IBI3032

Treatment:

Drug: IBI3032

Multiple ascending dose3 of placebo administered orally.

Placebo Comparator group

Description:

Cohort 3 placebo

Treatment:

Drug: placebo

Multiple ascending dose5 of placebo administered orally.

Placebo Comparator group

Description:

Cohort 5 placebo

Treatment:

Drug: placebo

Multiple ascending dose1 of IBI3032 administered orally.

Experimental group

Description:

Cohort 1 IBI3032

Treatment:

Drug: IBI3032

Multiple ascending dose2 of placebo administered orally.

Placebo Comparator group

Description:

Cohort 2 placebo

Treatment:

Drug: placebo