This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity receiving positive airway pressure (PAP) therapy. Eligible participants will be screened and randomized to the HDM1005 group or the placebo group at a ratio of 1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.
Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.
Beijing Anzhen Hospital
Beijing, China
Percentage change in body weight from baseline at week 52
Time frame: 52 week
Change in AHI from baseline at week 52
Time frame: 52 week
Percentage change in AHI from baseline
Time frame: 52 week
Proportion of participants with ≥50% reduction in AHI from baseline
Time frame: 52 week
Proportion of participants achieving the following criteria:AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10
Time frame: 52 week
Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, or ≥ 15% relative to baseline
Time frame: 52 week
Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment
Time frame: 52 week
Proportion of subjects reporting improvement in Patient Global Impression of Severity (PGIS)-OSA categories at Week 52 of treatment
Time frame: 52 week
Incidence of adverse events (AEs)
Time frame: 52 week
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