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← All trials/NCT07794397

Not yet recruitingPhase 3

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

Asset

HDM1005

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

-

Estimated enrollment

200

Study population

Obesity / overweight, Sleep apnea

Eligibility highlights

•BMI ≥28

Primary endpoints

•Body weight•AHI

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07794397
Org study IDHDM1005-305

Timeline

Milestones

Study first posted2026-08-31actual
Last update posted2026-08-31actual
Study start2026-09estimated (month precision)
Primary completion2028-09estimated (month precision)
Study completion2028-11estimated (month precision)

Assets

Investigational agents

HDM1005

Who this study enrolls

Obesity / overweightSleep apnea

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
6
Weight & body composition
2
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Primary/protocol endpoint

Percentage change in body weight from baseline at week 52

Time frame:52 week

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects whose body weight decreased by ≥ 5%, ≥ 10%, or ≥ 15% relative to baseline

Time frame:52 week

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence of adverse events (AEs)

Time frame:52 week

event count, event

Other (unclassified)

6 endpoints
Primary/protocol endpoint/low confidence

Change in AHI from baseline at week 52

Time frame:52 week

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percentage change in AHI from baseline

Time frame:52 week

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proportion of participants with ≥50% reduction in AHI from baseline

Time frame:52 week

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proportion of participants achieving the following criteria：AHI < 5; or 5 ≤ AHI ≤ 14 and Epworth Sleepiness Scale (ESS) score ≤ 10

Time frame:52 week

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment

Time frame:52 week

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Proportion of subjects reporting improvement in Patient Global Impression of Severity (PGIS)-OSA categories at Week 52 of treatment

Time frame:52 week

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.