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 Not Receiving Positive Airway Pressure (PAP) Therapy

NCT07787260 | Not Yet Recruiting Phase 3

• 1 other identifier: HDM1005-304
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity not receiving positive airway pressure (PAP) therapy. Eligible participants will be screened and randomized to the HDM1005 group or the placebo group at a ratio of 1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.

Conditions

Obstructive Sleep Apnea (OSA) and Obesity

Outcome Measures

Primary Outcomes (2)

• Percentage change in body weight from baseline at week 52

  52 week

• Change in AHI from baseline at week 52

  52 week

Secondary Outcomes (7)

• Percentage change in AHI from baseline

  52 week

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

  52 week

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

  52 week

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

  52 week

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

  52 week

Study Arms (2)

HDM1005

EXPERIMENTAL

Drug: HDM1005

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HDM1005 DRUG

Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose, the intervention will last for 52 weeks in total.

HDM1005

Placebo DRUG

Initiate at a once weekly dose of 0.5 mg and followed a dose escalation regimen, with dose increases every 4 weeks aiming at reaching the maintenance dose. The intervention will last for 52 weeks in total.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xueran Li

CONTACT

0571-89908523; cxylixueran@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 26, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

CN (1)