NCT07836140已完成2 期
An Investigator-Initiated, Randomized, Open-Label, Active-Controlled Study Comparing the Effects of BGM0504 Injection Versus Semaglutide Injection on Insulin Sensitivity and Body Weight in Obese Subjects
Second Affiliated Hospital of Soochow University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月22日最近更新:
适应症
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
- 60
- 试验地点
- 1
- 主要终点
- HOMA2-β index
研究概览
简要总结
An Investigator-Initiated, Randomized, Open-Label, Active-Controlled Study Comparing the Effects of BGM0504 Injection versus Semaglutide Injection on Insulin Sensitivity and Body Weight in Obese Subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Chinese adult participants aged 18 to 65 years (inclusive) with obesity, both male and female; 2.Obese individuals: BMI ≥ 30.0 kg/m², or BMI ≥ 27.0 kg/m² with at least one weight-related comorbidity (such as prediabetes, dyslipidemia, fatty liver disease, obstructive sleep apnea syndrome, metabolic abnormalities, etc.); 3.Prior to screening, participants must have maintained weight control through diet and exercise alone for at least 12 weeks, with a reported weight change of less than 5.0%, and must be able to continue their existing diet and exercise regimen for weight management throughout the trial period； 4.MRI (Magnetic Resonance Imaging scan) has no contraindications (e.g., use of pacemakers and metal implants, or claustrophobia that hinders completion of the MRI examination)； 5.Fully understand the purpose, nature, methods, and potential adverse reactions of the trial, be capable of completing the trial in accordance with the protocol requirements, voluntarily serve as a study participant, and sign the informed consent form； 6.Individuals who, from the time of signing the informed consent form until one month after the conclusion of the study, have no plans for pregnancy, voluntarily adopt effective contraceptive measures to prevent pregnancy or impregnation of their partner, and have no plans to donate sperm or eggs； Note: The percentage change in body weight is calculated as follows: (Body weight 12 weeks prior to screening - Body weight at screening) / Body weight 12 weeks prior to screening × 100%.
排除标准
- •1.Subjects with uncontrolled hypertension at screening (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening) or those with untreated blood pressure meeting the above criteria； 2.During screening, there was thyroid dysfunction that could not be controlled with a stable medication dose, or thyroid function test results showed clinically significant abnormalities requiring the initiation of treatment； 3.During screening, abdominal ultrasound indicates the presence of gallstones or polyps, or there are clinical symptoms of gallbladder disease at the time of screening； 4.During screening, severe chronic complications of diabetes requiring acute treatment are identified, such as diabetic nephropathy, proliferative retinopathy, or non-proliferative diabetic retinopathy; peripheral vascular disease leading to amputation, chronic foot ulcers, or intermittent claudication; and painful diabetic neuropathy； 5.It is known that the individual has an allergic constitution (allergic to three or more foods or medications), is allergic to GLP-1 receptor agonist drugs, or suffers from severe allergic diseases (asthma, urticaria, eczema, dermatitis, etc.) during screening； 6.Individuals with a history of severe diseases affecting the nervous, respiratory, immune, hepatic, renal, or other organ systems are deemed unsuitable for participation in the trial based on investigator assessment； 7.Individuals with severe mental illness or language barriers who are unwilling or unable to fully understand and cooperate during screening； 8.Individuals who tested positive for drugs in urine screening or alcohol in breath testing at baseline； 9.History of substance abuse； 10.Select individuals who have participated in any clinical study within the past three months and received intervention with an investigational drug or medical device； 11.Female subjects who are pregnant or breastfeeding； Note：The researchers believe that the subject has any other factors that would make participation in this trial inappropriate.
研究组 & 干预措施
BGM0504
Experimental
Multiple ascending doses of BGM0504 administered SC
干预措施: BGM0504 Administered SC (Drug)
Semaglutide
Active Comparator
Multiple ascending doses of Semaglutide administered SC
干预措施: semaglutide (Drug)
结局指标
主要结局
HOMA2-β index
时间窗: Target dose at week 16
Change in the HOMA2-β (steady-state model for beta-cell function assessment) index from baseline at Week 16 of the target dosage
HOMA2-IR
时间窗: Target dose at week 16
Change in the HOMA2-IR (homeostasis model assessment of insulin resistance) index from baseline at Week 16 of the target dose
MFI
时间窗: Target dose at week 16
Target dose: relative percentage change in skeletal muscle fat infiltration (MFI) from baseline at Week 16
次要结局
- Fasting insulin(Target dose at week 16)
- Fasting blood glucose(Target dose at week 16)
- Fasting C-peptide(Target dose at week 16)
- Fasting glucagon(Target dose at week 16)
- OGTT(At 30 minutes, 60 minutes, and 120 minutes compared to the baseline.)
- Fasting weight(Target dose at week 16)
- Serum uric acid (UA)(Target dose at week 16)
- Triglycerides (TG)(Target dose at week 16)
- Cholesterol (TC)(Target dose at week 16)
- Low-density lipoprotein (LDL-C)(Target dose at week 16)
- High-density lipoprotein (HDL-C)(Target dose at week 16)
- Free Fatty Acids (FFA)(Target dose at week 16)
- ACTH and cortisol(Target dose at week 16)
- Fat-free muscle volume (thigh skeletal muscle)(Target dose at week 16)
- Visceral fat(Target dose at week 16)
- Subcutaneous fat(Target dose at week 16)
- Liver fat(Target dose at week 16)
研究者
研究点 (1)
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