NCT07767942尚未招募3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of UBT251 Injection in Obese Participants With Moderate-to-severe Obstructive Sleep Apnea (OSA) Not on Positive Airway Pressure (PAP) Therapy（UNISHAPE-OSA-1）
The United Bio-Technology (Hengqin) Co., Ltd.0 个研究点目标入组 150 人开始时间: 2026年9月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Change from baseline in the Apnea-Hypopnea Index (AHI)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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:
- •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);
- •over-the-counter weight-loss drugs, prescription weight-loss drugs (e.g., orlistat), or lipolytic injections; stimulants, sedative-hypnotics, opioids, trazodone, or muscle relaxants;
- •medications that may affect excessive daytime sleepiness assessment.
- •History or evidence of:
- •Diagnosed with type 1 diabetes, type 2 diabetes, or other types of diabetes (except history of gestational diabetes);
- •History of acute or chronic pancreatitis, or pancreatic surgery;
- •History of symptomatic gallbladder disease within 1 year prior to screening;
- •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);
- •Presence of endocrine diseases that may significantly affect body weight;
- •History of bariatric surgery or planned weight-loss procedures (with specific exceptions for procedures >1 year prior);
- •Previous history of depression, or Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at screening, or history of severe mental illness;
- •positive C-SSRS for suicidal ideation/behavior;
- •History of clinically significant cardiovascular or cerebrovascular disease within 6 months;
- •History or presence of severe retinal or macular lesions;
- •History of sleep apnea surgery or major ENT surgery that may still affect breathing;
- •History or presence at screening of clinically relevant medical conditions (other than OSA) or psychiatric disorders related to insomnia or excessive sleepiness;
- •Receiving other active device therapies for OSA;
- •Presence of other sleep disorders besides OSA;
- •History or diagnosis of obesity hypoventilation syndrome or diurnal hypercapnia;
- •Requirement for supplemental oxygen therapy;
- •Severe craniofacial bony deformities or abnormalities significantly affecting the airway;
- •Presence of gastrointestinal motility disorders, gastrointestinal diseases increasing post-dose risks, or history of major gastrointestinal surgery;
- •malignancy within 5 years (except cured skin, cervical, or prostate in situ);
- •Major surgery, severe trauma, or severe infection within 1 month;
- •Concomitant diseases affecting participant safety, efficacy evaluation, or compliance.
- •Abnormal lab results:
- •HbA1c ≥6.5% or FPG ≥7.0 mmol/L;
- •ALT/AST ≥3×ULN or total bilirubin ≥1.5×ULN or eGFR <60 mL/min/1.73m²;
- •calcitonin ≥50 pg/mL;
- •uncontrolled thyroid dysfunction or TI-RADS ≥4a nodules;
- •fasting TG ≥5.6 mmol/L;
- •amylase/lipase >2×ULN;
- •hemoglobin <90 g/L;
- •untreated hypertension (SBP ≥160 and/or DBP ≥100 mmHg);
- •clinically significant ECG abnormalities (2nd/3rd degree AV block, QTcF >470ms female/>450ms male, WPW, HR <50 or >110);
- •positive HBV-DNA, HCV-RNA, HIV, or dual-positive syphilis;
- •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.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
UBT251 Dose 2
Experimental
Participants will receive UBT251 subcutaneously (SC).
干预措施: UBT251 (Drug)
UBT251 Dose 1
Experimental
Participants will receive UBT251 subcutaneously (SC).
干预措施: UBT251 (Drug)
结局指标
主要结局
Change from baseline in the Apnea-Hypopnea Index (AHI)
时间窗: Baseline, Week 52
次要结局
- 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(Baseline, Week 52)
- Percentage change from baseline in body weight(Baseline, Week 52)
- Percentage of participants with a reduction in AHI ≥ 50% from baseline and a reduction in body weight ≥ 10% from baseline(Baseline, Week 20, Week 52)
- Percentage change from baseline in AHI(Baseline, Week 52)
- Percentage of participants with a reduction in AHI ≥ 50% from baseline(Baseline, Week 52)
- Percentage change from baseline in the Sleep Apnea-Specific Hypoxia Burden (SASHB)(Baseline, Week 20, Week 52)
- Change from baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a and PROMIS Sleep Disturbance Short Form 8b scores(Baseline, Week 20, Week 52)
- Percentage of participants with improvement in the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire(Baseline, Week 20, Week 52)
研究者
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