Can a weekly shot ease sleep apnea and shed pounds?
NCT ID NCT07787260
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This phase 3 trial is testing whether an investigational drug called HDM1005, given as a once-weekly injection, can improve obstructive sleep apnea and reduce body weight in people with obesity who do not use positive airway pressure (PAP) therapy. About 200 adults aged 18 to 75 with a BMI of 28 or higher will receive either HDM1005 or a placebo for 52 weeks, alongside diet and exercise counseling. The study measures changes in the apnea-hypopnea index (AHI), which tracks breathing pauses during sleep, and body weight from the start to week 52.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HDM1005, an investigational drug given as a once-weekly injection
- What this could lead to
- If successful, this could offer a medication-based option to reduce sleep apnea severity and body weight in people who cannot or do not use CPAP machines.
- What could go wrong
- This is an early-stage test in a specific group, and results may not apply to everyone. The drug may cause side effects or fail to show meaningful improvement over placebo.
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 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
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: * 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.
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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
Beijing, China
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