NCT06226090已完成2 期
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 314 人开始时间: 2024年2月21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
- 314
- 试验地点
- 1
- 主要终点
- Percentage relative change from baseline in body weight at week 24
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, parallel phase 2 study to evaluate efficacy, safety, pharmacokinetic characteristics and immunogenicity of TG103 injection for weight management in non-diabetic patients with overweight in the presence of comorbidities or obesity, in addition to lifestyle intervention.
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, 18 years ≤ age ≤ 75 years.
- •Body Mass Index (BMI) ≥ 28 kg/m^2, or 24 kg/m^2 < BMI ≤ 28 kg/m^2 with at least one of obesity-related complications.
- •Regular diet and exercise and stable body weight (i.e., self-reported body weight change < 5%) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
- •Weight loss less than 5% or no weight loss after diet and exercise intervention for at least 12 weeks.
排除标准
- •History of type 2 diabetes, type 1 diabetes or hypoglycemia.
- •Overweight or obesity due to disease or drug; or weight increase due to non-fat mass increase; or monogenic obesity.
- •Medications or products which are judged by investigators to cause change in weight and influence trial evaluations have been used within 12 weeks before screening or will be used during study.
- •Weight loss less than 5% by monotherapy or combination with GLP-1 receptor agonists for at least 12 weeks before screening.
- •Bariatric surgery within 12 months before screening; or no full recovery from any surgery or injury at screening; or gastrointestinal motility dysfunction due to gastrointestinal surgery.
- •Participation in any clinical trial to receive treatment within 12 weeks before screening, or participation in clinical trial to receive TG103 before screening.
- •History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or suspected allergy to TG103 judged by investigator due to other severe allergy history.
- •Personal history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
- •History or screening ultrasound reports of chronic pancreatitis, acute pancreatitis, etc.
- •History of severe gastrointestinal disease; or gastrointestinal symptom at screening; or discontinuation of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG receptor agonist or metformin due to gastrointestinal adverse reaction.
- •Severe infection at screening.
- •Skin disorder that influences safety evaluation at screening.
- •History of severe disease or malignant tumor.
- •Systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥ 100 mmHg, NYHA Grade Ⅲ-Ⅳ, QTc interval prolongation or severe arrhythmia at screening.
- •History of abnormal thyroid function with requirement of medication treatment at screening, or screening TSH beyond the normal reference range.
- •One of the followings at screening: 1) HbA1c ≥ 6.5%, or FPG ≥ 7.0mmol/L or<2.8mmol/L; 2) calcitonin ≥ 50 ng/L; 3) ALT or AST>3 × UNL (upper normal limit), or total bilirubin>1.5 × UNL; 4) blood amylase or lipase>1.5 × UNL, 5) TG>5.6mmol/L, 6) eGFR<60ml/min/1.73m^2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody, 8) WBC< 3×10^9/L, or Hb <100g/L, 9) INR>1.
- •History of drug abuse, drug dependence or alcoholism.
- •History of moderate to severe depression, or screening Patient Health Questionaire-9 (PHQ-9) score ≥
- •The fertile female who is pregnant, breast-feeding or with blood HCG positive at screening; or the fertile participants and their partner cannot use an effective contraceptive method during the trial and within 3 months after the end of treatment.
- •Other situations unsuitable for this study in the investigator's opinion.
研究组 & 干预措施
TG103 7.5 mg
Experimental
干预措施: TG103 7.5 mg (Drug)
Placebo 7.5 mg
Placebo Comparator
干预措施: Placebo 7.5 mg (Drug)
TG103 15 mg
Experimental
干预措施: TG103 15 mg (Drug)
Placebo 15 mg
Placebo Comparator
干预措施: Placebo 15 mg (Drug)
TG103 22.5 mg
Experimental
干预措施: TG103 22.5 mg (Drug)
Placebo 22.5 mg
Placebo Comparator
干预措施: Placebo 22.5 mg (Drug)
结局指标
主要结局
Percentage relative change from baseline in body weight at week 24
时间窗: From baseline to week 24
次要结局
- Change from baseline to week 24 in systolic blood pressure(From baseline to week 24)
- Proportion of participants with weight loss of ≥ 10% at week 24(From baseline to week 24)
- Change from baseline to week 24 in waist circumference(From baseline to week 24)
- Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol(From baseline to week 24)
- Relative change from baseline in body weight at week 24(From baseline to week 24)
- Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol(From baseline to week 24)
- Title: Change from baseline to week 24 in serum triglyceride(From baseline to week 24)
- Proportion of participants with weight loss of ≥ 5% at week 24(From baseline to week 24)
- Change from baseline to week 24 in diastolic blood pressure(From baseline to week 24)
- Title: Change from baseline to week 24 in serum total cholesterol(From baseline to week 24)
研究者
研究点 (1)
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