Can a weekly shot ease sleep apnea and shed weight?

NCT ID NCT07794397

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether an investigational drug called HDM1005, given as a weekly injection, can help people with obstructive sleep apnea and obesity. Participants will receive either HDM1005 or a placebo for 52 weeks, alongside lifestyle counseling on diet and physical activity. The study measures changes in body weight and the apnea-hypopnea index, which tracks breathing pauses during sleep. The goal is to see if the drug can reduce weight and improve sleep apnea severity in people who already use positive airway pressure (PAP) therapy.

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 weekly injection
What this could lead to
If it works, HDM1005 could offer a new way to reduce weight and improve sleep apnea symptoms in people who use PAP therapy, potentially easing their reliance on the device.
What could go wrong
This is a phase 3 trial, but success is not guaranteed. The drug may cause side effects, and the benefits might not be large enough to change standard care. Results will take time to confirm.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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. * ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG. 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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Anzhen Hospital

    Beijing, China

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