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UBT251 Injection Phase Ⅲ Study (OSA-PAP)

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

About this trial

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.

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 have received stable positive airway pressure (PAP) therapy for at least 3 months prior to screening and who plan to continue PAP therapy throughout the study.

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.

. Diagnosed with type 1, type 2 diabetes mellitus or other types of diabetes mellitus (history of gestational diabetes mellitus excluded);

. History of acute or chronic pancreatitis or pancreatic surgery;

. History of symptomatic gallbladder disease within 1 year prior to screening (excluding participants who underwent cholecystectomy completed at least 3 months before screening without long-term complications); or gallstones and/or bile duct stones detected by abdominal ultrasound at screening, assessed by the investigator to require treatment, likely to require treatment during the study, or other gallbladder lesions judged by the investigator to potentially compromise participant safety;

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 the AHI

Time frame
Baseline, Week 52
2

Proportion of participants with ≥50% reduction in Apnea-Hypopnea Index (AHI) from baseline

Time frame
Baseline, Week 52
3

Percentage change from baseline in body weight

Time frame
Baseline, Week 52
4

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

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: