A Study of IBI362 9 mg in Chinese Adults With Obesity

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06164873
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IBI362 — DRUG
    Once-weekly injections of gradually increased doses of IBI362
  • Placebo — DRUG
    Once-weekly injections of volume-matched placebo

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Key Dates

Start date
Dec 27, 2023
Status verified
Aug 2024
Primary completion
Jun 27, 2025
Completion
Sep 19, 2025

Study Design

Enrollment
462 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: IBI362

Primary Outcome Measure

Percent Change from Baseline in Body Weight [ Time Frame: Week 60 ]

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