A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity

NCT06974851 | Recruiting Phase 3

• 1 other identifier: HRS9531-306
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects with Obstructive Sleep Apnea (OSA) and Obesity

Conditions

Bstructive Sleep Apnea (OSA) and Obesity

Outcome Measures

Primary Outcomes (1)

• Percentage Change in AHI from Baseline at Week 52 of Treatment

  52week

Secondary Outcomes (9)

• Changes in AHI Relative to Baseline After 52 Weeks of Treatment

  52week

• Proportion of Subjects with AHI <5.0 events/h, or AHI 5.0-14.0 events/h with Epworth Sleepiness Scale (ESS) ≤10 at Week 52 of Treatment

  52week

• Percentage Change in Body Weight from Baseline at Week 52 of Treatment

  52week

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

  52week

• Proportion of Subjects Achieving ≥5%, ≥10%, ≥15%, and ≥20% Reduction in Body Weight from Baseline at Week 52 of Treatment

  52week

Study Arms (2)

Group 1: HRS9531

EXPERIMENTAL

Drug: HRS9531

Group 2: HRS9531placebo

PLACEBO COMPARATOR

Drug: HRS9531placebo

Interventions

HRS9531 DRUG

HRS9531

Group 1: HRS9531

HRS9531placebo DRUG

HRS9531placebo

Group 2: HRS9531placebo

Eligibility Criteria

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

You may qualify if:

• The participant has provided informed consent and is willing and able to comply with the study protocol requirements to complete the study.
• Age between 18 and 75 years, male or female, at the time of signing the informed consent form.
• BMI ≥ 28.0 kg/m² at screening.
• Has been on a controlled diet and exercise regimen for 3 months or more, with a weight change of ≤ 5.0 kg in the past 3 months.
• Polysomnography (PSG) results at screening confirm OSA.
• Female participants of childbearing potential and male participants with partners of childbearing potential agree to use highly effective contraception from the time of signing the informed consent form until 2 months after the last dose, with no plans for pregnancy or donation of eggs/sperm during this period. Female participants of childbearing potential must have a negative pregnancy test within 3 days prior to randomization and must not be breastfeeding.

You may not qualify if:

• Laboratory Test Abnormalities:
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 2.0 × ULN.
• Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula based on serum creatinine).
• Thyroid-stimulating hormone (TSH) \< 0.4 or \> 6.0 mIU/L.
• Other laboratory abnormalities judged by the investigator to potentially affect efficacy or safety assessments.
• Clinically Significant ECG Abnormalities:
• ECG findings deemed clinically significant by the investigator, including but not limited to myocardial infarction, severe arrhythmias (e.g., supraventricular tachycardia, atrial fibrillation, atrial flutter, second- or third-degree atrioventricular block, etc.), which may affect participant safety.
• Poorly Controlled Blood Pressure:
• Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
• PHQ-9 Score ≥ 15:
• Patient Health Questionnaire-9 (PHQ-9) score ≥ 15.
• Medical History or Conditions Prior to Screening or Randomization:
• Endocrine disorders or monogenic mutations causing obesity or hereditary obesity syndromes that may significantly affect weight.
• Diabetes mellitus.
• Diagnosis of central or mixed sleep apnea or Cheyne-Stokes respiration.

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

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

Yadi Tang

CONTACT

0518-82342973; yadi.tang.yt37@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: April 24, 2025
• First Posted: May 16, 2025
• Study Start: July 25, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-04

Locations

CN (1)