Phase III Trial of UBT251 in Moderate-to-Severe OSA With Obesity: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.
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... [+6]
Known hypersensitivity to the investigational drug, its excipients, or other dru... [+33]