A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06931028
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • placebo — OTHER
    placebo administered subcutaneously (SC) once a week.
  • IBI362 — DRUG
    Once-weekly injections of gradually increased doses of IBI362

Study Details

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg/m2. 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 4-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
Jun 12, 2025
Status verified
Jun 2025
Primary completion
May 7, 2027
Completion
Jun 11, 2027

Study Design

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

Arms

  • Placebo Comparator: placebo
    Participants receive placebo by subcutaneous (SC) injection once a week.
  • Experimental: IBI362
    ①2mg, SC, once a week\* 4weeks; ②4mg, SC, once a week\* 4weeks；③6mg, SC, once a week\* 4weeks，9mg,SC,once a week\* 36weeks

Primary Outcome Measure

Change from Baseline in Apnea-Hypopnea Index (AHI) [ Time Frame: Week 48 ]

Central Contacts

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