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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Male or female subjects, age 18-65(both inclusive) at the time of signing informed consent.

At screening visit, BMI 24-42kg/m2(both inclusive)

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.

At screening visit, AHI ≥15 and Obstructive Sleep Apnea on PSG

Disqualifiers

Endocrine disorders that may significantly affect body weight, or obesity or hereditary obesity syndrome due to a single gene mutation;

Diabetes (except gestational diabetes)

There are diseases that may require systemic glucocorticoid therapy during the study period

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.

Trial design

Treatments tested in this trial

  • HRS9531 Injection
  • HRS9531 Injection
  • Placebo Injection

Treatment groups

108 Participants
are divided into 3 treatment groups

Locations

This trial has no locations