NCT05299697Unknown2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study of TG103 Injection in the Management of 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 195 人开始时间: 2022年5月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Relative change from baseline in body weight at week 24
研究概览
简要总结
This study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase II study to evaluate efficacy, safety, pharmacokinetics characteristics and immunogenicity of two dose levels of TG103 injection, a GLP-1 receptor agonist, in the management of overweight or obesity, to support dose selection for further development.
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
- Single (Participant)
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. <5 kg self-reported change) within 12 weeks before screening as well as body weight ≥ 60 kg at screening.
- •Weight loss less than 5% or weight increase after simple diet and exercise efforts for at least 3 months.
- •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
- •Screening HbA1c ≥ 6.5%, or screening FPG ≥ 7.0mmol/L or<2.8mmol/L, or history of diabetes mellitus or hypoglycemia.
- •Overweight or obesity due to single gene mutation, disease or drug, or weight increase due to non-fat mass increase.
- •Treatment with any medication or product which in the investigator's opinion will cause change in weight to influence trial evaluations within 12 weeks before screening or during this study.
- •Subjects who underwent bariatric surgery within 12 months before screening, or are not yet recovered from any surgery or injury at screening.
- •Subjects who participated in any clinical trial and received the treatment within 12 weeks before screening, or who participated in the clinical trial and received treatment with TG103 injection.
- •History of allergy or suspected allergy to GLP-1 receptor agonists or antibody agents, or other severe allergy history based on which the subjects may be allergic to the study drugs in investigator's opinion.
- •Personal history or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2), or screening calcitonin ≥ 50 ng/L.
- •Previous history or screening ultrasound includes one of the following: chronic pancreatitis, acute pancreatitis, gallstone with at least one of less than 5mm, choledocholithiasis, except that there was no cholelithiasis after treatment or cholecystectomy.
- •No recovery from gastrointestinal disease or symptom at screening, or previous withdrawl of GLP-1 receptor agonist, GLP-1/GIP receptor agonist, GLP-1/GCG receptor agonist or metformin by gastrointestinal adverse drug reaction, or previous history of gastrointestinal surgery that influences the gastrointestinal motility in the investigators' opinions.
- •Acute infection at screening.
- •History of easily relapsed skin disease (e.g. urticaria), or present skin injury in any administration site at screening.
- •History of acute coronary syndrome, stroke, severe asthma, epilepsy, systemic lupus erythematosus, hemolytic anemia, cirrhosis and the other severe disease, or history of malignant tumor.
- •One of the followings at screening: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg, or NYHA ≥ grade III, or QTc interval prolongation (i.e. QTcF>450ms in males or >470ms in females) or severe arrhythmia (e.g. atrioventricular block equal to or more than II degree, ventricular tachycardia).
- •History of abnormal thyroid function with requirement of medication treatment at screening, or TSH beyond the normal reference range at screening.
- •One of the followings at screening: 1) ALT or AST>3 × UNL (upper normal limit), or total bilirubin>1.5 × UNL, 2) blood amylase or lipase>1.5 × UNL, 3) TG>5.6mmol/L, 4) eGFR<60ml/min/1.73m^2 (calculated by CKD-EPI formula), 5) HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody positive, 6) WBC< 3×10^9/L, or Hb <100g/L, 7) 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 male or female cannot use an effective contraceptive method during the trial and for 3 months after the end of treatment.
- •Other situations that are not suitable for the study in the investigator's opinion.
研究组 & 干预措施
TG103 15 mg
Experimental
Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 15 mg.
干预措施: TG103 15 mg (Drug)
TG103 22.5 mg
Experimental
Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 22.5 mg.
干预措施: TG103 22.5 mg (Drug)
Placebo
Placebo Comparator
Administered subcutaneously (s.c., under the skin) once every week for 24 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Relative change from baseline in body weight at week 24
时间窗: From baseline to week 24
percent change in body weight
次要结局
- Change from baseline to 12 weeks and 24 weeks in TG（triglyceride）(From baseline to week 24)
- Change from baseline to 12 weeks and 24 weeks in HbA1c(From baseline to week 24)
- Change from baseline to 12 weeks, 24 weeks and 27 weeks in BMI(From baseline to week 27)
- Change from baseline to 12 weeks and 24 weeks in fasting C peptide(From baseline to week 24)
- Change from baseline to 12 weeks and 24 weeks in HOMA-IR(From baseline to week 24)
- Change from baseline to 12 weeks and 24 weeks in systolic blood pressure and diastolic blood pressure(From baseline to week 24)
- Number of TEAEs and SAEs from baseline to week 27(From baseline to week 27)
- Relative change from baseline in body weight (%) at week 12 and week 27(From baseline to week 27)
- Proportion of subjects with weight loss of ≥ 5% and ≥ 10% of baseline body weight at week 12 and week 24(From baseline to week 24)
- Change from baseline to 12 weeks, 24 weeks and 27 weeks in body weight(From baseline to week 27)
- Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist circumference(From baseline to week 27)
- Change from baseline to 12 weeks and 24 weeks in LDLC（low density lipoprotein cholesterol）(From baseline to week 24)
- Change from baseline to 12 weeks and 24 weeks in scores of the patient health questionnaire (PHQ-9)(From baseline to week 24)
- Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist to hip circumference ratio(From baseline to week 27)
- Change from baseline to 12 weeks and 24 weeks in FPG (fasting plasma glucose)(From baseline to week 24)
- Change from baseline to 12 weeks and 24 weeks in FINS (fasting insulin)(From baseline to week 24)
- Change from baseline to 12 weeks and 24 weeks in TC（total cholesterol）(From baseline to week 24)
- Change from baseline to 12 weeks and 24 weeks in HDLC（high density lipoprotein cholesterol）(From baseline to week 24)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)Acquired Thrombotic Thrombocytopenic PurpuraNCT04021173Lee's Pharmaceutical Limited74
已完成
2 期
Phase II Study of Hemay005 in Patients With Active Ankylosing SpondylitisActive Ankylosing SpondylitisNCT05407246Tianjin Hemay Pharmaceutical Co., Ltd90
进行中（未招募）
2 期
A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)NCT06643481Novartis Pharmaceuticals251
终止
2 期
Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative ColitisColitis, UlcerativeNCT03893565GlaxoSmithKline104
Unknown
2 期
Arformoterol/Budesonide for COVID-19Coronavirus InfectionNCT05055414Korea United Pharm. Inc.140