A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy

NCT ID: NCT06994650

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-01-31

Brief Summary

This study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of HRS-9531 injection in obese subjects with obstructive sleep apnea (OSA) who are on positive airway pressure ventilation (PAP) therapy.

Conditions

Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HRS9531

Group Type: EXPERIMENTAL

HRS9531

Intervention Type: DRUG

HRS9531 will be administered by Subcutaneous injection

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching Placebo will be administered by Subcutaneous injection

Interventions

HRS9531

HRS9531 will be administered by Subcutaneous injection

Intervention Type: DRUG

Placebo

Matching Placebo will be administered by Subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Shengdi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Siai Sun

Role: CONTACT

siai.sun@hengrui.com

18036618062

Other Identifiers

HRS9531-307

Identifier Type: -

Identifier Source: org_study_id