Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/Obesity

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07469800
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • IBI362 — DRUG
    IBI362 will be administered subcutaneously once weekly (QW) in a step-up dose titration regimen over 48 weeks: * Weeks 1-4: 2 mg QW * Weeks 5-8: 4 mg QW * Weeks 9-24: 6 mg QW * Weeks 25-48: 6/9 mg QW.
  • Placebo — DRUG
    Matching placebo will be administered subcutaneously once weekly (QW) for 48 weeks, with the same number of injections as the IBI362 group to maintain study blinding.

Study Details

A multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and safety of IBI362 in participants with mild to moderate hypertension complicated by overweight/obesity who have not received antihypertensive drug treatment

Key Dates

Start date
Apr 23, 2026
Status verified
May 2026
Primary completion
Aug 1, 2026
Completion
Apr 15, 2027

Study Design

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

Arms

  • Experimental: IBI362 treatment Group
  • Placebo Comparator: Placebo Control Group

Primary Outcome Measure

To evaluate the effect of IBI362 on mean sitting systolic blood pressure (msSBP) compared with placebo at Week 16 of treatment. [ Time Frame: Week 16 ]

Central Contacts

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