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

NCT07767942 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-08-17

No results posted yet for this study

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

Conditions

  • Obstructive Sleep Apnea, Obesity

Interventions

DRUG

UBT251

Administered SC

DRUG

UBT251

Administered SC

DRUG

Placebo

Administered SC

Sponsors & Collaborators

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

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-18
Primary Completion
2028-09-30
Completion
2028-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07767942 on ClinicalTrials.gov