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IBI3042 Study in Healthy Participants and Overweight or Obese Participants

NCT07793019 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-08-28

No results posted yet for this study

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.

Conditions

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) .

Sponsors & Collaborators

  • Innovent Biologics (Suzhou) Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-06
Completion
2028-01-26

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07793019 on ClinicalTrials.gov