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RECRUITING
NCT07793019
PHASE1

IBI3042 Study in Healthy Participants and Overweight or Obese Participants

Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase 1 study of IBI3042, an investigational oral medicine being developed as a potential treatment for overweight and obesity. The study has two parts. Part A will evaluate single doses of IBI3042 in healthy adults. Part B will evaluate repeated doses for 13 weeks in adults with overweight or obesity. The main goal is to assess the safety and tolerability of IBI3042. The study will also evaluate how IBI3042 is processed in the body and explore its effects on body weight and other metabolic measures. Some participants will receive placebo, and some Part B groups will also receive orforglipron for comparison.

Official title: A Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single-Dose IBI3042 in Healthy Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-09-07

Completion Date

2028-01-26

Last Updated

2026-09-11

Healthy Volunteers

Yes

Interventions

DRUG

Orforglipron

Oral, corresponding dose regimen according to study cohort (including Part B) .

DRUG

Matching Placebo

Oral, matching to IBI3042, corresponding dose regimen according to study cohort (including Part A, Part B) .

DRUG

IBI3042

Oral, corresponding dose regimen according to study cohort (including Part A, Part B) .

Locations (1)

Peking University First Hospital

Beijing, Beijing Municipality, China