Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07000955
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This study is a multicenter, randomized, partially double-blind (double-blind in both the IBI362 group and the placebo group, with the tirbopeptide group open), placebo and active drug controlled design study

Key Dates

Start date
Jun 17, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
May 14, 2027

Study Design

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

Arms

  • Experimental: IBI362
    Stage 1: subcutaneous injection, qw; dose ranging from 2.0mg to 15.0mg，44w Stage 2: subcutaneous injection, q2w; 12.0mg or 15.0mg, 12w;
  • Placebo Comparator: Placebo
    Stage 1: subcutaneous injection, 0mg, qw, 44w Stage 2: subcutaneous injection, dose ranging from 2.0mg to 6.0mg，qw, 12w
  • Active Comparator: Tirzepatide
    Open label: subcutaneous injection, qw, dose ranging from 2.5mg to 15.0mg, 44w

Primary Outcome Measure

The Incidence of adverse events and serious adverse events during the treatment period [ Time Frame: week 44 ]

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