A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
NCT06226090
Phase
Phase 2
Recruitment status
Completed
Participants
Lead sponsor
CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
Start date
2024-02-21
Number of sites
- Summary
- 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.
- Short title
- A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 2 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2024-10-24
- First posted
- 2024-01-26
- Registry last updated
- 2025-05-14
- Primary completion date
- 2024-09-26
- Start date
- 2024-02-21
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06226090
- ClinicalTrials.gov ID
- NCT06226090
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Sources for study design
Percentage relative change from baseline in body weight at week 24
Timeframe: From baseline to week 24
Proportion of participants with weight loss of ≥ 5% at week 24
Timeframe: From baseline to week 24
Proportion of participants with weight loss of ≥ 10% at week 24
Timeframe: From baseline to week 24
Change from baseline to week 24 in waist circumference
Timeframe: From baseline to week 24
Relative change from baseline in body weight at week 24
Timeframe: From baseline to week 24
Change from baseline to week 24 in systolic blood pressure
Timeframe: From baseline to week 24
Change from baseline to week 24 in diastolic blood pressure
Timeframe: From baseline to week 24
Title: Change from baseline to week 24 in serum total cholesterol
Timeframe: From baseline to week 24
Title: Change from baseline to week 24 in serum triglyceride
Timeframe: From baseline to week 24
Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol
Timeframe: From baseline to week 24
Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol
Timeframe: From baseline to week 24
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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>1.2.
- 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's opinion.
Sources for eligibility
- Clinical Trials Information GroupShijiazhuang, China
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Obesity disorder Primary condition