Clinical trial

UBT251 Injection Phase Ⅲ Study (OSA-NPAP)

Opening soon · Phase 3 · 0 countries · Registry ID NCT07767942

Opening soonPhase 3Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObstructive Sleep Apnea, Obesity

Full registry criteria

Inclusion Criteria: * 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. * Weight has been stable for 3 months prior to screening (body weight change \< 5%) (based on self-report). * Participants of childbearing potential and their partners must have no plan for conception from screening until 6 months after completion of the trial, voluntarily use effective contraceptive measures, and have no plan to donate sperm or oocytes within 6 months after trial completion. * Willingness to provide written informed consent and strictly comply with the protocol. Exclusion Criteria: * Known hypersensitivity to the investigational drug, its excipients, or other drugs with similar pharmacological activity. * Use of any of the following within 3 months prior to screening: 1. GLP-1 receptor agonists or similar drugs; 2. biguanides, SGLT-2 inhibitors, DPP-4 inhibitors, or any other hypoglycemic agents; 3. weight-influencing medications (including systemic glucocorticoids, tricyclic antidepressants, antipsychotics, mood stabilizers); 4. over-the-counter weight-loss drugs, prescription weight-loss drugs (e.g., orlistat), or lipolytic injections; stimulants, sedative-hypnotics, opioids, trazodone, or muscle relaxants; 5. medications that may affect excessive daytime sleepiness assessment. * History or evidence of: 1. Diagnosed with type 1 diabetes, type 2 diabetes, or other types of diabetes (except history of gestational diabetes); 2. History of acute or chronic pancreatitis, or pancreatic surgery; 3. History of symptomatic gallbladder disease within 1 year prior to screening; 4. Personal or family history (first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); 5. Presence of endocrine diseases that may significantly affect body weight; 6. History of bariatric surgery or planned weight-loss procedures (with specific exceptions for procedures \>1 year prior); 7. Previous history of depression, or Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at screening, or history of severe mental illness; 8. positive C-SSRS for suicidal ideation/behavior; 9. History of clinically significant cardiovascular or cerebrovascular disease within 6 months; 10. History or presence of severe retinal or macular lesions; 11. History of sleep apnea surgery or major ENT surgery that may still affect breathing; 12. History or presence at screening of clinically relevant medical conditions (other than OSA) or psychiatric disorders related to insomnia or excessive sleepiness; 13. Receiving other active device therapies for OSA; 14. Presence of other sleep disorders besides OSA; 15. History or diagnosis of obesity hypoventilation syndrome or diurnal hypercapnia; 16. Requirement for supplemental oxygen therapy; 17. Severe craniofacial bony deformities or abnormalities significantly affecting the airway; 18. Presence of gastrointestinal motility disorders, gastrointestinal diseases increasing post-dose risks, or history of major gastrointestinal surgery; 19. malignancy within 5 years (except cured skin, cervical, or prostate in situ); 20. Major surgery, severe trauma, or severe infection within 1 month; 21. Concomitant diseases affecting participant safety, efficacy evaluation, or compliance. * Abnormal lab results: 1. HbA1c ≥6.5% or FPG ≥7.0 mmol/L; 2. ALT/AST ≥3×ULN or total bilirubin ≥1.5×ULN or eGFR \<60 mL/min/1.73m²; 3. calcitonin ≥50 pg/mL; 4. uncontrolled thyroid dysfunction or TI-RADS ≥4a nodules; 5. fasting TG ≥5.6 mmol/L; 6. amylase/lipase \>2×ULN; 7. INR \>ULN; 8. hemoglobin \<90 g/L; 9. untreated hypertension (SBP ≥160 and/or DBP ≥100 mmHg); 10. clinically significant ECG abnormalities (2nd/3rd degree AV block, QTcF \>470ms female/\>450ms male, WPW, HR \<50 or \>110); 11. positive HBV-DNA, HCV-RNA, HIV, or dual-positive syphilis; 12. Physical examination, vital signs, laboratory tests, or other assessments showing clinically significant abnormalities that pose a significant risk to the participant or interfere with the evaluation of safety or PK results, rendering the participant unsuitable for the trial. * Participation in another interventional clinical trial within 3 months prior to screening. * Blood loss ≥400 mL or blood transfusion within 3 months prior to screening. * History of drug or alcohol abuse (female \>7 or male \>14 standard drinks/week). * Pregnant or lactating women. * Unable to tolerate venipuncture or history of needle/blood phobia. * Any other condition deemed unsuitable by the investigator.

Treatments and study arms

UBT251

Drug

Administered SC

UBT251

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

Change from baseline in the Apnea-Hypopnea Index (AHI)Baseline, Week 52

Study locations

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No public site location was included in this record. Check the original registry for updates.