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A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE2

A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea (OSA)

NCT06565871•Fujian Shengdi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female subjects, age 18-65(both inclusive) at the time of signing informed consent.
•2. At screening visit, BMI 24-42kg/m2(both inclusive)
•3. Self-reported Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
•4. At screening visit, AHI ≥15 and Obstructive Sleep Apnea on PSG

Exclusion Criteria

•1. Endocrine disorders that may significantly affect body weight, or obesity or hereditary obesity syndrome due to a single gene mutation;
•2. Diabetes (except gestational diabetes)
•3. There are diseases that may require systemic glucocorticoid therapy during the study period
•4. Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of screening Visit .Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion.
•5. Previous or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)
•6. In or suspected of depression, bipolar disorder, suicidal tendencies, schizophrenia or other more serious mental illness;
•7. Use of drugs or treatments that may lead to significant weight gain or loss within 3 months, use of stimulants and hypnotics, mirtazapine, opioids, trazodone within 3 months;
•8. Patients with a history of blood donation or blood loss ≥400 ml within 3 months prior to screening, or receiving blood transfusions within 3 months
•9. During the screening or before randomization ,laboratory examination meets the following conditions:
•Fasting blood glucose ≥7.0 mmol/L, or HbA1c ≥6.5%; Hemoglobin \<100 g/L; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× upper limit of normal range (ULN), total bilirubin (TBIL) ≥2.0×ULN; Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73 m2 (calculated based on serum creatinine using CKD-EPI formula); Fasting triglyceride (TG) \>5.64 mmol/L (500 mg/dl); calcitonin ≥50 ng/L; Blood amylase or lipase ≥3×ULN; Thyroid stimulating hormone (TSH) \<0.4 or \>6.0 mIU/L; Abnormalities in other laboratory tests that the investigator determines may affect the assessment of efficacy or safety;
+1 more criteria

Key Dates

Start Date

August 1, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

August 22, 2024

Enrollment

108

ESTIMATED participants

Conditions

Weight Management

Interventions

HRS9531 Injection

DRUG

HRS9531 Injection

DRUG

Placebo Injection

DRUG

Contacts

Shuang Li

CONTACT

0518-82342973 Shuang.li.sl100@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea

Inclusion Criteria

Exclusion Criteria

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