Obstructive Sleep Apnea, Obesity / UBT251 · Phase 3 Trial

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

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned Phase 3 randomized, double-blind, placebo-controlled trial of the investigational drug UBT251 for moderate-to-severe obstructive sleep apnea with obesity. No results have been reported in this registry record; the study is not yet recruiting and has not yet generated efficacy or safety data.

What was studied

Phase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Obstructive Sleep Apnea, Obesity; age from 18 Years; to 75 Years. Intervention: UBT251 Dose 1; UBT251 Dose 2. Compared with: Placebo — Placebo Comparator. n = 150. Multicenter (specific locations not stated in registry record)..

Key findings

Safety

Efficacy, safety, and tolerability data are not available in this record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a planned Phase 3 trial with no results reported; the registry record describes the protocol and planned endpoints only, not outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change from baseline in the Apnea-Hypopnea Index (AHI) (assessed at Baseline, Week 52)

DesignPhase 3, Interventional, Randomized, Parallel, Double masking, Treatment purpose

PopulationObstructive Sleep Apnea, Obesity; age from 18 Years; to 75 Years

Sample size150

InterventionUBT251 Dose 1; UBT251 Dose 2

ComparatorPlacebo — Placebo Comparator

SettingMulticenter (specific locations not stated in registry record).

Reported figures

Quoted from the source exactly as published.

Planned enrollment150

PhasePhase 3

Primary outcome measureChange from baseline in Apnea-Hypopnea Index (AHI) at Week 52

Treatment duration52 weeks

Intervention frequencyWeekly subcutaneous injections

Caveats

This is a study registration only; no results are reported and recruitment has not yet begun.
Efficacy, safety, and tolerability data are not available in this record.
No sample size justification or power calculation is provided in the registry entry.
No interim or final results have been posted to support any clinical decision-making.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized, double-blind, placebo-controlled, multicenter Phase 3 design.

Directness

strong

Hard clinical outcome (AHI) in the target population (moderate-to-severe OSA with obesity).

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

strong

Double-blind, placebo-controlled design with protocol-specified visits reduces risk of bias.

Sample adequacy

insufficient

Planned enrollment 150 participants; adequacy for primary endpoint not justified in record.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07767942). This is a study registration, not published results. Lead sponsor: The United Bio-Technology (Hengqin) Co., Ltd.. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Obstructive Sleep Apnea, Obesity. Interventions: DRUG: UBT251; DRUG: UBT251; DRUG: Placebo. Primary outcome measures: Change from baseline in the Apnea-Hypopnea Index (AHI) , Baseline, Week 52. Brief 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

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07767942Obstructive Sleep Apnea, ObesityUBT251The United Bio-Technology (Hengqin) Co.