IBI3042 Study in Healthy Participants and Overweight or Obese Participants

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07793019
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Orforglipron — DRUG
    Oral, corresponding dose regimen according to study cohort (including Part B) .
  • Matching Placebo — DRUG
    Oral, matching to IBI3042, corresponding dose regimen according to study cohort (including Part A, Part B) .
  • IBI3042 — DRUG
    Oral, corresponding dose regimen according to study cohort (including Part A, Part B) .

Study Details

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.

Key Dates

First listed
Aug 28, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 6, 2027
Completion
Jan 26, 2028

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Drug: IBI3042 (Part A)
    IBI3042,oral. Corresponding dose regimen according to study cohort.
  • Experimental: Investigational Drug: IBI3042 (Part B)
    IBI3042,oral. Corresponding dose regimen according to study cohort.
  • Placebo Comparator: Matching Placebo (Part B)
    Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort.
  • Active Comparator: Orforglipron (Part B)
    Orforglipron, oral. Corresponding dose regimen according to study cohort.
  • Placebo Comparator: Matching Placebo (Part A)
    Placebo matching to IBI3042, oral. Corresponding dose regimen according to study cohort.

Primary Outcome Measure

Number of Participants With Adverse Events (Part A) [ Time Frame: through study completion, an average of 29 days ]

Central Contacts

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