A Multicenter, Randomized, Double-blind, Placebo-controll... | NCT06994650

Studies
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

Sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Jan 26, 2026Actual

Enrollment

140Estimated

Phase

Phase 3

Conditions

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

Interventions

HRS9531
Placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 13, 2025Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Jan 2027Estimated

First Submitted Date

May 20, 2025

First Submission Date that Met QC Criteria

May 20, 2025

First Posted Date

May 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2026

Last Update Posted Date

Jan 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

140Estimated

Label	Type	Description	Intervention Names
HRS9531	Experimental		Drug: HRS9531
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
HRS9531	Drug	HRS9531 will be administered by Subcutaneous injection	HRS9531

Measure	Description	Time Frame
The change of AHI form baseline after 52 weeks of treatment		52 weeks

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided