Obesity, Obstructive, Sleep Apnea
Conditions
Brief summary
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.
Interventions
OTHERplacebo
placebo administered subcutaneously (SC) once a week.
DRUGIBI362
Once-weekly injections of gradually increased doses of IBI362
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 been used for at least 4 weeks prior to screening. * For all subjects: 1. Age ≥18 years at the time of signing informed consent. 2. Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour. 3. Body mass index (BMI) ≥28.0 kg/m² at screening.
Exclusion criteria
For PAPs： * Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study * Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study For all subjects： * Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). * Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline * Have significant craniofacial abnormalities that may affect breathing at baseline * Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia. * Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study. * Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator. * Have achieved a \>5% change in body weight through diet and exercise alone for at least 12 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Apnea-Hypopnea Index (AHI) | Week 48 | AHI is defined as the average number of apnea and hypopnea events per hour of sleep, which is determined by polysomnography. The lower the value, the better, and the normal range is \<5 events/hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change from Baseline in Body Weight | Week 48 | — |
| Change from Baseline in Systolic Blood Pressure (SBP) | Week 48 | — |
| Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 | Week 48 | — |
| Percentage of Participants with ≥50% AHI Reduction from Baseline | Week 48 | — |
| Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) | Week 48 | SASHB is an indicator that quantifies the cumulative effect of hypoxia caused by apnea or hypopnea events during sleep. It is also calculated based on the results of polysomnography. It combines the severity, duration and frequency of hypoxia, and can more comprehensively reflect the systemic damage of hypoxia to the body. It is an important predictive factor for increased CVD risk. The lower the value, the better. |
| Percent Change from Baseline in Apnea-Hypopnea Index (AHI) | Week 48 | AHI is defined as the average number of apnea and hypopnea events per hour of sleep, which is determined by polysomnography. The lower the value, the better, and the normal range is \<5 events/hour. |
Countries
China
Contacts
Primary Contactbaiyi yan
Outcome results
None listed