NCT06994650Active, not recruitingPhase 3
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
This study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of HRS-9531 injection in obese subjects with obstructive sleep apnea (OSA) who are on positive airway pressure ventilation (PAP) therapy.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 144 (actual)
- First submitted
- 20 May 2025
- Start date
- 13 Aug 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT06994650
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 144
- From 13 Aug 2025 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior/planned OSA-related major surgeries (e.g., tonsillectomy/adenoidectomy) that may affect breathing.
- Have used drugs or treatments that may cause significant weight gain or loss within 3 months
- Investigator-determined unsuitability/unwillingness to pause PAP therapy for at least 1 week pre-PSG (e.g., safety/occupational/personal considerations).
Other illness
- Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes excluded.
- Diabetes mellitus (excluding gestational diabetes).
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- Impaired gastric emptying (e.g., gastric bypass, pyloric stenosis);Chronic use of GI motility-affecting drugs;Severe GI disorders (e.g., active PUD, IBD);GI surgeries (except non-motility-affecting procedures)
- Pancreatic disorders (acute/chronic pancreatitis, pancreatic injury);Acute cholecystitis history;Symptomatic/treated gallbladder disease
Other
- Have significant craniofacial abnormalities that may affect breathing at baseline
- Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
Who the study is looking for
- Aged 18 -75 (inclusive), male or female Sex
- BMI ≥28.0 kg/m2;
- ≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months.
- Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events/h.
- ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.
- Females/males of childbearing potential must use highly effective contraception from consent until 2 months post-treatment, with no pregnancy/donation plans. Females require negative pregnancy test ≤3 days pre-randomization and non-lactating.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.