NCT07177469已完成2 期
A Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Overweight/Obese Patients
The United Bio-Technology (Hengqin) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2025年3月14日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
This randomized, double-blind, parallel, placebo-controlled phase II study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients
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)
盲法说明
double-blind
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
- •Age between 18 and 75 years, inclusive, of any gender;
- •Body mass index (BMI) ≥28.0 kg/m² or 24.0 kg/m² ≤ BMI < 28.0 kg/m² accompanied by at least one of the following: a. Prediabetes, hypertension, dyslipidemia, or fatty liver; b. Weight-bearing joint pain; c. Obesity-induced dyspnea or obstructive sleep apnea syndrome;
- •Stable body weight for 3 months prior to screening;
- •No fertility plans from screening to 6 months after study completion, willing to use contraceptive measures, and no sperm or egg donation plans within 6 months after study completion;
- •Fully informed about the study and voluntarily signed the written informed consent form.
排除标准
- •Known hypersensitivity to the investigational drug or its formulation excipients, or to other GLP-1 receptor agonist drugs, or a history of clinically significant multiple or severe drug allergies, or current allergic diseases, or high sensitivity constitution;
- •History of use of any of the following drugs or treatments within the specified periods prior to screening: 1) GLP-1 receptor agonists, GLP-1R/GCGR agonists, or GLP-1R/GIPR/GCGR agonists within 3 months before screening; 2) Over-the-counter weight-loss drugs or appetite suppressants within 3 months before screening, or prescription weight-loss drugs or lipolytic injectables within 3 months before screening; 3) Drugs likely to affect body weight (e.g.systemic glucocorticoids, tricyclic antidepressants, antipsychotics, or antiepileptics) for ≥2 consecutive weeks within 3 months before screening or expected during the trial; 4) Antidiabetic drugs (e.g.metformin, SGLT2 inhibitors,thiazolidinediones) within 3 months before screening;
- •History or evidence of any of the following diseases: 1) Diagnosis of type 1 diabetes, type 2 diabetes, or other types of diabetes; 2) History of acute or chronic pancreatitis or pancreatic surgery; 3) Symptomatic gallbladder disease within 2 years before screening (defined as imaging evidence of gallstones with doctor-diagnosed abdominal pain attributable to gallstones); subjects who have undergone cholecystectomy and/or cholelithiasis treatment without long-term complications may participate; 4) Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; 5) Secondary obesity due to disease or medication; 6) History of bariatric surgery (excluding: acupuncture for weight loss, liposuction, or abdominal liposuction performed >1 year before screening; gastric banding removed >1 year before screening; intragastric balloon removed >1 year before screening; duodenal-jejunal bypass sleeve removed >1 year before screening); 7) History of depression or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening; or history of severe mental illness (including suicidal ideation/attempts, schizophrenia, bipolar disorder, etc.); 8) Clinically significant cardiovascular disease within 6 months before screening (defined as: i. Myocardial infarction or unstable angina; ii. Cardiac surgery; iii. Congestive heart failure; iv. Cerebrovascular accident, including stroke/transient ischemic attack; v. Other cardiovascular diseases deemed unsuitable for the trial by the investigator); 9) History of retinal disease; 10) History of severe hypoglycemia or recurrent symptomatic hypoglycemia; 11) Concurrent gastroparesis or other gastrointestinal motility disorders, uncontrolled gastroesophageal reflux disease, or gastrointestinal diseases that increase the risk of adverse events with medication use; 12) Major surgery, severe trauma, or severe infection within 1 month before screening, as judged by the investigator to be unsuitable for the trial; 13) History of malignant tumors; 14) Limb deformities or disabilities that prevent accurate measurement of height, weight, or other indicators; 15) Concurrent diseases (e.g.neurological, endocrine, mental diseases) that, in the investigator's opinion, may affect subject safety, efficacy evaluation, or compliance;
- •Screening abnormalities in any of the following tests: 1) HbA1c ≥6.5% or fasting blood glucose (FBG) ≥7.0 mmol/L; if FBG is 6.1-6.9 mmol/L at screening, an oral glucose tolerance test (OGTT) is required, and subjects with 2-hour post-load blood glucose ≥11.1 mmol/L will be excluded; 2) Hepatic or renal impairment (serum ALT and/or AST ≥3 times the upper limit of normal [ULN]; serum total bilirubin ≥1.5×ULN; estimated glomerular filtration rate [eGFR] <60 mL·min-¹·1.73m-² according to local laboratory reference ranges); 3) Serum calcitonin ≥50 pg/mL; 4) Thyroid dysfunction (confirmed by clinical assessment and/or abnormal thyroid-stimulating hormone [TSH]) with hyperthyroidism or hypothyroidism that may increase patient risk; 5) Fasting triglycerides ≥5.6 mmol/L; 6) Serum amylase or lipase >2.0×ULN; 7) International normalized ratio (INR) above the normal range at screening; 8) Hemoglobin <110 g/L (male) or <100 g/L (female); 9) Untreated or poorly controlled hypertension; 10) Clinically significant electrocardiogram (ECG) abnormalities at screening; 11) Diagnosis of hypokalemia or hypomagnesemia at screening; 12) Physical examination, vital signs, or laboratory findings with clinically significant abnormalities that, in the investigator's judgment, pose a major risk to the subject or interfere with safety, pharmacokinetic (PK), or pharmacodynamic (PD) result evaluation;
- •Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) above the reference value, positive hepatitis C virus (HCV) antibody with HCV ribonucleic acid (RNA) exceeding the reference range upper limit, positive human immunodeficiency virus (HIV) antibody, or positive syphilis antibody at screening;
- •Blood loss or blood donation exceeding 400 mL within 3 months before screening, or receipt of blood or blood component transfusions; or concurrent hemoglobinopathies, hemolytic anemia, or sickle cell anemia;
- •Participation in other clinical trials within 3 months before screening;
- •History of drug or alcohol abuse, defined as female subjects consuming >7 standard drinks per week or male subjects consuming >14 standard drinks per week;
- •Pregnant or lactating women;
- •Inability to tolerate venipuncture or history of fainting or dizziness during blood draws;
- •Other conditions deemed unsuitable for participation in the clinical trial by the investigator.
研究组 & 干预措施
UBT251 Injection 2.0 mg
Experimental
Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 0.5 mg subcutaneous injection with increasing doses at 5, 9weeks to 1.0 mg and 2.0 mg once weekly.
干预措施: UBT251 Injection 2.0 mg and UBT251 Injection Placebo (Drug)
UBT251 Injection 4.0 mg（ID 0.5 mg）
Experimental
Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 0.5 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 1.0 mg, 2.0 mg and 4.0 mg once weekly.
干预措施: UBT251 Injection 4.0 mg (ID 0.5 mg) and UBT251 Injection Placebo (Drug)
UBT251 Injection 4.0 mg（ID 1.0 mg）
Experimental
Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 1.0 mg subcutaneous injection with increasing doses at 5 and 9 weeks to 2.0 mg and 4.0 mg once weekly.
干预措施: UBT251 Injection 4.0 mg (ID 1.0 mg) and UBT251 Injection Placebo (Drug)
UBT251 Injection 6.0 mg
Experimental
Each subject will receive UBT251 Injection and UBT251 Injection Placebo, s.c. once weekly for 24 weeks. The starting dose of UBT251 Injection will be 1.0 mg subcutaneous injection with increasing doses at 5, 9 and 13 weeks to 2.0 mg, 4.0 mg and 6.0 mg once weekly.
干预措施: UBT251 Injection 6.0 mg and UBT251 Injection Placebo (Drug)
结局指标
主要结局
Body Weight
时间窗: Week 24
Percentage change in body weight from baseline after 24 weeks of treatment
次要结局
- Mental Health Status(Through study completion, an average of six months)
- Waist Circumference(Week 24)
- BMI(Week 24)
- Fasting Serum Lipids(Week 24)
- Systolic blood pressure(Week 24)
- Diastolic blood pressure(Week 24)
- HbA1c(Week 24)
- Adverse Events(Through study completion, an average of six months)
- Plasma Concentration(Through study completion, an average of six months)
- Serum Anti-UBT251 Antibody Incidence(Through study completion, an average of six months)
- Titre and neutralizing antibody testing of antibody-positive samples(Through study completion, an average of six months)
- ECG(Through study completion, an average of six months)
- Respiration in breaths per minute by investigator(Through study completion, an average of six months)
- Temperature in degree Celsius by thermometer(Through study completion, an average of six months)
- Pulse in beats per minute by investigator(Through study completion, an average of six months)
- Abnormal findings in physical examination by investigator(Through study completion, an average of six months)
研究者
研究点 (1)
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