Study S002788

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）

ClinicalTrials.gov record

Registration

Registration: NCT07767942
Acronym: UNISHAPE-OSA-1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: NOT_YET_RECRUITING
Enrollment: 150
Start: 2026-09-18
Primary completion: 2028-09
Lead sponsor: The United Bio-Technology (Hengqin) Co., Ltd.
Conditions: Obstructive Sleep Apnea, Obesity
Interventions: DRUG:UBT251; DRUG:Placebo
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change from baseline in the Apnea-Hypopnea Index (AHI) [Baseline, Week 52]

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