New injection could ease sleep apnea in obese patients
NCT ID NCT06994650
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 3 trial tests an injectable drug called HRS9531 in 140 obese adults with moderate-to-severe obstructive sleep apnea who already use a breathing machine (PAP). The study aims to see if the drug reduces the number of breathing pauses during sleep and helps with weight loss over 52 weeks. Participants are randomly assigned to receive either the drug or a placebo injection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS9531 injection
- What this could lead to
- If successful, this could offer a new treatment option to reduce sleep apnea severity and aid weight loss in obese patients already using a breathing machine.
- What could go wrong
- This is a phase 3 trial, but results may not apply to all patients. Side effects from the drug are possible, and the benefit over placebo is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 18 -75 (inclusive), male or female Sex 2. BMI ≥28.0 kg/m2; 3. ≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months. 4. Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events/h. 5. ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG. 6. 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. Exclusion Criteria: 1. Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes excluded. 2. Diabetes mellitus (excluding gestational diabetes). 3. Prior/planned OSA-related major surgeries (e.g., tonsillectomy/adenoidectomy) that may affect breathing. 4. Have significant craniofacial abnormalities that may affect breathing at baseline 5. Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration 6. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator. 7. 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) 8. Pancreatic disorders (acute/chronic pancreatitis, pancreatic injury);Acute cholecystitis history;Symptomatic/treated gallbladder disease 9. Have used drugs or treatments that may cause significant weight gain or loss within 3 months 10. Investigator-determined unsuitability/unwillingness to pause PAP therapy for at least 1 week pre-PSG (e.g., safety/occupational/personal considerations).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, 100044, China
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- Real-world evaluation of the clinical performance and safety of apneal dx for the screening and aid in the diagnosis of obstructive sleep apnea-hypopnea syndrome in adults: a post-market clinical follow-up study
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