A Study of IBI3032 in Chinese Participants With Overweight or Obesity

NCT07170319 | Active Not Recruiting Phase 1

• 1 other identifier: CIBI3032T002
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight or Obesity

Outcome Measures

Primary Outcomes (3)

• 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

  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

  Baseline up to Day 43

• Number of Participants with adverse events (AEs)

  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.

Secondary Outcomes (6)

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

  Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

• maximum concentration (Cmax) of IBI3032

  Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

• time to maximum concentration (Tmax) of IBI3032

  Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

• clearance (CL) of IBI3032

  Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

• apparent volume of distribution (V) of IBI3032

  Day 1 and Day 28：Predose up to 24 hours postdose. Day 8, Day 15 and Day 22：Predose up to 4 hours postdose.

Study Arms (10)

Multiple ascending dose5 of IBI3032 administered orally.

EXPERIMENTAL

Cohort 5 IBI3032

Drug: IBI3032

Multiple ascending dose1 of placebo administered orally.

PLACEBO COMPARATOR

Cohort 1 placebo

Drug: placebo

Multiple ascending dose4 of placebo administered orally.

PLACEBO COMPARATOR

Cohort 4 placebo

Drug: placebo

Multiple ascending dose3 of IBI3032 administered orally.

EXPERIMENTAL

Cohort 3 IBI3032

Drug: IBI3032

Multiple ascending dose4 of IBI3032 administered orally.

EXPERIMENTAL

Cohort 4 IBI3032

Drug: IBI3032

Multiple ascending dose2 of IBI3032 administered orally.

EXPERIMENTAL

Cohort 2 IBI3032

Drug: IBI3032

Multiple ascending dose3 of placebo administered orally.

PLACEBO COMPARATOR

Cohort 3 placebo

Drug: placebo

Multiple ascending dose5 of placebo administered orally.

PLACEBO COMPARATOR

Cohort 5 placebo

Drug: placebo

Multiple ascending dose1 of IBI3032 administered orally.

EXPERIMENTAL

Cohort 1 IBI3032

Drug: IBI3032

Multiple ascending dose2 of placebo administered orally.

PLACEBO COMPARATOR

Cohort 2 placebo

Drug: placebo

Interventions

IBI3032 DRUG

IBI3032. Method of administration: oral, fasted administration.

Multiple ascending dose1 of IBI3032 administered orally.; Multiple ascending dose2 of IBI3032 administered orally.; Multiple ascending dose3 of IBI3032 administered orally.; Multiple ascending dose4 of IBI3032 administered orally.; Multiple ascending dose5 of IBI3032 administered orally.

placebo DRUG

Placebo (without active ingredients). Method of administration: oral, fasted administration.

Multiple ascending dose1 of placebo administered orally.; Multiple ascending dose2 of placebo administered orally.; Multiple ascending dose3 of placebo administered orally.; Multiple ascending dose4 of placebo administered orally.; Multiple ascending dose5 of placebo administered orally.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics Technology Limited (Shanghai R&D Center): lead

Study Sites (1)

The Frist Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 12, 2025
• Study Start: September 25, 2025
• Primary Completion: December 24, 2025
• Study Completion: March 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)