NCT05997576已完成3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 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 675 人开始时间: 2023年11月22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
- 已完成
- 发起方
- 入组人数
- 675
- 试验地点
- 1
- 主要终点
- Proportion of participants with weight loss of ≥ 5% at week 40
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase 3 study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of TG103 injection, a GLP-1 receptor agonist, for weight management in non-diabetic patients with BMI greater than or equal to 28 kg/m2 or greater than 24 kg/m2 in the presence of comorbidities, in addition to lifestyle intervention (calorie restrict diet and increased physical activity).
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.
- •Be able to understand the trial and complete the procedures, and be voluntary to participate in this study and sign the informed consent.
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 screening 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/1.73m2 , 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 22.5 mg
Experimental
Administered subcutaneously once every week for 52 weeks. Doses gradually increased to 22.5 mg.
干预措施: TG103 22.5 mg (Drug)
Placebo
Placebo Comparator
Administered subcutaneously once every week for 52 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of participants with weight loss of ≥ 5% at week 40
时间窗: From baseline to week 40
Weight loss is percentage change at week 40 compared with baseline.
Relative percentage change from baseline in body weight at week 40
时间窗: From baseline to week 40
Weight loss is percentage change at week 40 compared with baseline.
次要结局
- Relative percentage change from baseline in body weight at week 52(From baseline to week 52)
- Proportion of participants with weight loss of ≥ 5% at week 52(From baseline to week 52)
- Proportion of participants with weight loss of ≥ 10%(From baseline to week 40, 52)
- Change from baseline in body weight (kg)(From baseline to week 40, 52)
- Change from baseline in waist circumference (cm)(From baseline to week 40, 52)
- Change from baseline in HbA1c (%)(From baseline to week 40, 52)
- Change from baseline in fasting plasma glucose (mmol/L)(From baseline to week 40, 52)
- Change from baseline in total cholesterol (mmol/L)(From baseline to week 40, 52)
- Change from baseline in triglyceride (mmol/L)(From baseline to week 40, 52)
- Change from baseline in high density lipoprotein cholesterol (mmol/L)(From baseline to week 40, 52)
- Change from baseline in systolic blood pressure (mmHg)(From baseline to week 40, 52)
- Change from baseline in diastolic blood pressure (mmHg)(From baseline to week 40, 52)
- Change from baseline in fasting insulin (mU/L)(From baseline to week 40, 52)
- Change from baseline in low density lipoprotein cholesterol (mmol/L)(From baseline to week 40, 52)
研究者
研究点 (1)
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