Obstructive Sleep Apnea (OSA) and Obesity
Conditions
Brief summary
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.
Interventions
DRUGHDM1005
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.
DRUGPlacebo
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.
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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. * ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.
Exclusion criteria
* 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. * Respiratory or neuromuscular diseases judged by the investigator to potentially interfere with trial results. * Clinical abnormalities or diseases related to insomnia or excessive sleepiness (excluding OSA). * Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs). * History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening. * History of severe cardiovascular or cerebrovascular diseases within the past six months. * The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline at week 52 | 52 week |
| Change in AHI from baseline at week 52 | 52 week |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in AHI from baseline | 52 week |
| Proportion of participants with ≥50% reduction in AHI from baseline | 52 week |
| Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10 | 52 week |
| Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, or ≥ 15% relative to baseline | 52 week |
| Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment | 52 week |
| Proportion of subjects reporting improvement in Patient Global Impression of Severity (PGIS)-OSA categories at Week 52 of treatment | 52 week |
| Incidence of adverse events (AEs) | 52 week |
Countries
China
Contacts
CONTACTXueran Li
Outcome results
None listed