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

NCT06994650 | Recruiting Phase 3

• 1 other identifier: HRS9531-307
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The change of AHI form baseline after 52 weeks of treatment

  52 weeks

Secondary Outcomes (4)

• The percentage change in AHI from baseline after 52 weeks of treatment

  52 weeks

• The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;

  52 weeks

• The percentage of subjects with AHI <5.0 events /h, or AHI ranging from 5.0 to 14.0 events/h and Epworth Sleepiness Scale (ESS) ≤10 after 52 weeks of treatment;

  52 weeks

• The percent change in body weight from baseline after 52 weeks of treatment.

  52 weeks

Study Arms (2)

HRS9531

EXPERIMENTAL

Drug: HRS9531

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HRS9531 DRUG

HRS9531 will be administered by Subcutaneous injection

HRS9531

Placebo DRUG

Matching Placebo will be administered by Subcutaneous injection

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:

• Aged 18 -75 (inclusive), male or female Sex
• BMI ≥28.0 kg/m2；
• ≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months.
• Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events/h.
• ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.
• 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.

You may not qualify if:

• Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes excluded.
• Diabetes mellitus (excluding gestational diabetes).
• Prior/planned OSA-related major surgeries (e.g., tonsillectomy/adenoidectomy) that may affect breathing.
• Have significant craniofacial abnormalities that may affect breathing at baseline
• Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
• Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
• 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)
• Pancreatic disorders (acute/chronic pancreatitis, pancreatic injury)；Acute cholecystitis history；Symptomatic/treated gallbladder disease
• Have used drugs or treatments that may cause significant weight gain or loss within 3 months
• Investigator-determined unsuitability/unwillingness to pause PAP therapy for at least 1 week pre-PSG (e.g., safety/occupational/personal considerations).

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Central Study Contacts

Siai Sun

CONTACT

18036618062; siai.sun@hengrui.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: May 20, 2025
• First Posted: May 29, 2025
• Study Start: August 13, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-05

Locations

CN (1)