The objective of this clinical trial is to evaluate the efficacy of investigational drug UBT251 in the treatment of moderate-to-severe obstructive sleep apnea (OSA) with obesity, as well as to assess its safety. The key research question is:
Does UBT251 reduce the Apnea-Hypopnea Index (AHI) in participants?
UBT251 will be compared with placebo (an inactive substance identical in appearance) to determine its efficacy in treating moderate-to-severe OSA.
Participants will:
Receive weekly subcutaneous injections of either UBT251 or placebo for a duration of 52 weeks
Undergo examinations and testing at protocol-specified visit windows
Have their AHI assessed following the 52-week treatment period
Male or female participants aged 18 to 75 years inclusive at the time of signing the informed consent form.
Confirmed diagnosis of obstructive sleep apnea (OSA) based on the International Classification of Sleep Disorders, 3rd Edition, Text Revision (ICSD-3-TR) criteria, with a polysomnography (PSG) showing an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour at screening.
Participants who are unwilling or unsuitable to receive positive airway pressure (PAP) therapy, and who have not received PAP therapy within 4 weeks prior to screening.
Body Mass Index (BMI) ≥ 28 kg/m² at screening.
Known hypersensitivity to the investigational drug, its excipients, or other drugs with similar pharmacological activity.
Diagnosed with type 1 diabetes, type 2 diabetes, or other types of diabetes (except history of gestational diabetes);
History of acute or chronic pancreatitis, or pancreatic surgery;
History of symptomatic gallbladder disease within 1 year prior to screening;