A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Not Receiving Positive Airway Pressure (PAP) Therapy
HDM1005: 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.
Placebo: 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.
Study 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 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
* Unable or unwilling to receive PAP therapy before screening, and not planning to initiate PAP therapy during the study period.
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.
Primary outcome measure(s)
Percentage change in body weight from baseline at week 52 — 52 week
Change in AHI from baseline at week 52 — 52 week
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
China
More Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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