HDM1005 for Obstructive Sleep Apnea in People With Obesity Using Airway Pressure
Tests HDM1005 against placebo in adults with sleep apnea and obesity.
Plain-language title generated from the registry record
Registry title: 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 Receiving Positive Airway Pressure (PAP) Therapy
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07794397, who can take part
Where in China
- Beijing Anzhen HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Trial code
- NCT07794397
- Record updated
- 31 August 2026
- Original description
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.Read full original descriptionShow less
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 Receiving Positive Airway Pressure (PAP) Therapy
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.
Inclusion: 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: 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 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; 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); 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; Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration; 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.