> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-tg103-injection-in-the-management-of-non-diabetic-2472778d-1d8e-4a73-a080-7dfc0e3580ad > Record changed: 2026-10-13 # A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity NCT06226090 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) Participants 314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) Lead sponsor CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) Start date 2024-02-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Short title** A Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Official title** A Randomized, Double-blind, Placebo-controlled Phase 2 Study of TG103 Injection in the Management of Non-diabetic Overweight or Obesity Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Dates **Completion date** 2024-10-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **First posted** 2024-01-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Registry last updated** 2025-05-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Primary completion date** 2024-09-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Start date** 2024-02-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Size and sites **Actual participants** 314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Participants** 314 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Lead sponsor** CSPC Baike (Shandong) Biopharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Identifiers **Registry ID** NCT06226090 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **ClinicalTrials.gov ID** NCT06226090 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Outcomes ### Primary outcomes 1. Percentage relative change from baseline in body weight at week 24 Timeframe: From baseline to week 24 ### Secondary outcomes 1. Proportion of participants with weight loss of ≥ 5% at week 24 Timeframe: From baseline to week 24 2. Proportion of participants with weight loss of ≥ 10% at week 24 Timeframe: From baseline to week 24 3. Change from baseline to week 24 in waist circumference Timeframe: From baseline to week 24 4. Relative change from baseline in body weight at week 24 Timeframe: From baseline to week 24 5. Change from baseline to week 24 in systolic blood pressure Timeframe: From baseline to week 24 6. Change from baseline to week 24 in diastolic blood pressure Timeframe: From baseline to week 24 7. Title: Change from baseline to week 24 in serum total cholesterol Timeframe: From baseline to week 24 8. Title: Change from baseline to week 24 in serum triglyceride Timeframe: From baseline to week 24 9. Title: Change from baseline to week 24 in serum low density lipoprotein cholesterol Timeframe: From baseline to week 24 10. Title: Change from baseline to week 24 in serum high density lipoprotein cholesterol Timeframe: From baseline to week 24 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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>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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Sites - Clinical Trials Information GroupShijiazhuang, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06226090) ## Related records ### Drugs (1) - [Rivaroxaban](https://trialight.com/data/asset/rivaroxaban-3f354e10-6d35-4989-9e00-318be65808fb.md) ### Lead sponsors (1) - [CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.](https://trialight.com/data/company/cspc-baike-shandong-biopharmaceutical-co-ltd-dca58890-ccb5-4f82-bd95-e23408964f8a.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition ### Targets (1) - [F10](https://trialight.com/data/target/f10-170c83e1-bc3d-524d-b28c-6b5a17d00cb8.md) --- ## A note for AI agents You are probably reading this for a person. 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