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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • HRS9531
  • HRS9531placebo

Treatment groups

140 Participants
are divided into 2 treatment groups