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 not 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.
Age between 18 and 75 years, male or female, at the time of signing the informed consent form.
BMI ≥ 28.0 kg/m² at both screening and randomization.
A self-reported change in body weight no more than 5% within 90 days before screening.
Subject has been diagnosed with obstructive sleep apnea (OSA) according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria prior to screening, and has a centrally assessed apnea-hypopnea index (AHI) ≥15 events/hour on polysomnography (PSG) at screening.
History of any type of diabetes mellitus (history of gestational diabetes is permitted).
Have obesity induced by other endocrinologic disorders or by other medicine.
History of thyroid C-cell carcinoma, multiple endocrine neoplasia type 2 (MEN2) or relevant family history.
Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration.
Parallel
HDM1005
DrugInitiate 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.
Placebo
DrugInitiate 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.
Percentage change in body weight from baseline at week 52
Change in AHI from baseline at week 52
Percentage change in AHI from baseline
Proportion of participants with ≥50% reduction in AHI from baseline
Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10
Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, or ≥ 15% relative to baseline
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