A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
Recruiting
Phase 3
Interventional Study
Sleep Apnea
Obstructive
Obesity
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 260 (estimated)
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. · Industry
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About This Trial
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 tr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* For PAP s: Subjects who have received positive airway pressure (PAP) therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study.
* For non-PAP s:Subjects who are unable or unwilling to undergo PAP therapy. PAP must not have b…
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