A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity

Launched by CSPC BAIKE (SHANDONG) BIOPHARMACEUTICAL CO., LTD. · Jan 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new injection called TG103, which is being tested to help manage weight in adults who are overweight or obese but do not have diabetes. The researchers aim to find out how well TG103 works, how safe it is, and how it behaves in the body when combined with lifestyle changes like diet and exercise. The trial is currently active but not recruiting new participants.

To be eligible for this study, participants need to be between 18 and 75 years old and have a Body Mass Index (BMI) of 28 or higher, or a BMI between 24 and 28 with related health issues. They should also have tried diet and exercise for at least 12 weeks without losing significant weight. However, there are several exclusions, such as having a history of diabetes or certain other medical conditions. Participants in this trial can expect to receive either the TG103 injection or a placebo (which looks like the real treatment but has no active ingredients) and will be monitored closely throughout the study for their health and weight changes.

Gender

ALL

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., 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.
• Exclusion Criteria:
• • 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\&gt;5.6mmol/L, 6) eGFR\<60ml/min/1.73m\^2 , 7) positive of HBsAg, HCV-antibody, HIV-antibody or anti-TP antibody, 8) WBC\&lt; 3×10\^9/L, or Hb \&lt;100g/L, 9) INR\>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 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\&#39;s opinion.

Trial Officials