A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity
Trial Parameters
Brief Summary
A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects with Obstructive Sleep Apnea (OSA) and Obesity
Eligibility Criteria
Inclusion Criteria: 1. The participant has provided informed consent and is willing and able to comply with the study protocol requirements to complete the study. 2. Age between 18 and 75 years, male or female, at the time of signing the informed consent form. 3. BMI ≥ 28.0 kg/m² at screening. 4. 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. 5. Polysomnography (PSG) results at screening confirm OSA. 6. 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. Exclusion Criteria: 1. Laboratory Test Abnormalit