Health TrialsbyHealthPanel

UBT251 Injection Phase Ⅲ Study (OSA-NPAP)

ConditionObstructive Sleep Apnea, Obesity
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe United Bio-Technology (Hengqin) Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female participants aged 18 to 75 years inclusive at the time of signing the informed consent form.

Confirmed diagnosis of obstructive sleep apnea (OSA) based on the International Classification of Sleep Disorders, 3rd Edition, Text Revision (ICSD-3-TR) criteria, with a polysomnography (PSG) showing an Apnea-Hypopnea Index (AHI) ≥ 15 events/hour at screening.

Participants who are unwilling or unsuitable to receive positive airway pressure (PAP) therapy, and who have not received PAP therapy within 4 weeks prior to screening.

Body Mass Index (BMI) ≥ 28 kg/m² at screening.

Disqualifiers

Known hypersensitivity to the investigational drug, its excipients, or other drugs with similar pharmacological activity.

GLP-1 receptor agonists or similar drugs;

biguanides, SGLT-2 inhibitors, DPP-4 inhibitors, or any other hypoglycemic agents;

weight-influencing medications (including systemic glucocorticoids, tricyclic antidepressants, antipsychotics, mood stabilizers);

Trial design

Design model

Parallel

Treatments tested in this trial

  • UBT251

    Drug

    Administered SC

  • UBT251

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

150 Participants
are divided into 3 treatment groups
Group A: UBT251 Dose 1Experimental treatment 1 intervention
Group B: UBT251 Dose 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in the Apnea-Hypopnea Index (AHI)

Time frame
Baseline, Week 52

Secondary outcomes

1

Percentage change from baseline in AHI

Time frame
Baseline, Week 52
2

Percentage of participants with a reduction in AHI ≥ 50% from baseline

Time frame
Baseline, Week 52
3

Percentage of participants with an AHI < 5 events/hour or an AHI ≥ 5 and ≤ 14 events/hour with an Epworth Sleepiness Scale (ESS) score ≤ 10

Time frame
Baseline, Week 52
4

Percentage change from baseline in body weight

Time frame
Baseline, Week 52

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: