A Study of IBI362 in Participants With Obesity or Overweight

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT05607680
Phase
PHASE3
Status
Completed

Conditions

  • Obesity Or Overweight

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Placebo administered subcutaneously (SC) once a week.
  • IBI362 — DRUG
    IBI362 administered subcutaneously (SC) once a week.

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Key Dates

Start date
Nov 14, 2022
Status verified
Nov 2024
Primary completion
Aug 21, 2023
Completion
Apr 16, 2024

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo,SC,once a week for 48 weeks
  • Experimental: IBI362 4 mg
    2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks
  • Experimental: IBI362 6 mg
    2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 4 weeks 6 mg,SC,once a week for 40 weeks

Primary Outcome Measure

Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 32 ]

Related Studies