a study of tg103 injection in overweight or obesity

Conditions: Overweight or Obesity

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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\ 1.2. * history of drug abuse, drug dependence or alcoholism. * history of moderate to severe depression, or screening patient health questionaire-9 (phq-9) score ≥ 15. * 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.