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NOT YET RECRUITING
NCT07767942
PHASE3

Phase III Trial of UBT251 in Moderate-to-Severe OSA With Obesity: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.

Sponsor: The United Bio-Technology (Hengqin) Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of UBT251 Injection in Obese Participants With Moderate-to-severe Obstructive Sleep Apnea (OSA) Not on Positive Airway Pressure (PAP) Therapy(UNISHAPE-OSA-1)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-09-18

Completion Date

2028-10

Last Updated

2026-08-17

Healthy Volunteers

No

Interventions

DRUG

UBT251

Administered SC

DRUG

UBT251

Administered SC

DRUG

Placebo

Administered SC