Obesity / Obstructive Sleep Apnea / UBT251 · Phase 3 Trial

UBT251 Injection Phase Ⅲ Study (OSA-PAP)

ClinicalTrials.gov · September 8, 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 controlled trial comparing UBT251 to placebo in patients with moderate-to-severe obstructive sleep apnea on positive airway pressure therapy. No results are yet available; the study has not begun recruitment. The primary outcome is change in Apnea-Hypopnea Index at 52 weeks.

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.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

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

Plain-language summary

This is a Phase 3 trial registration with no posted results; the study is not yet recruiting and outcome data are not available in this registry record.

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

Reported figures

Quoted from the source exactly as published.

Planned sample size150

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

Treatment duration52 weeks

Intervention frequencyOnce-weekly subcutaneous injections

Caveats

This is a registry record only; no results are posted or available.
Study recruitment has not yet begun (NOT_YET_RECRUITING status).
No power calculation, allocation concealment method, or blinding procedures are described in the registry record.
Sample size of 150 is relatively small for Phase 3 and no justification is provided.

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, placebo-controlled Phase 3 intervention trial design.

Directness

strong

Primary outcome is AHI, a direct measure of obstructive sleep apnea severity.

Consistency

insufficient

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

Risk of bias

insufficient

Placebo control noted but blinding and allocation methods not detailed in registry.

Sample adequacy

insufficient

150 participants planned but underpowered for Phase 3; no power calculation reported.

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 (NCT07806851). 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: UBT251 will be compared with placebo (an inactive substance identical in appearance) to evaluate its therapeutic effect in participants with moderate-to-severe obstructive sleep apnea maintained on positive airway pressure therapy.Participants will complete the following study procedures:1. Receive once-weekly subcutaneous injections of either UBT251 or placebo for a total treatment period of 52 weeks, while remaining on stable positive airway pressure therapy;2. Undergo all examinations and tests within the visit windows specified in the trial protocol;3. Undergo assessment of the Apnea-Hypopnea Index (AHI) upon completion of 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.

ObesityObstructive Sleep ApneaNCT07806851UBT251The United Bio-Technology (Hengqin) Co.