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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG103 15 mg | Experimental | Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. Doses gradually increased to 15 mg. |
|
| 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. |
|
| Placebo | Placebo Comparator | Administered subcutaneously (s.c., under the skin) once every week for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG103 15 mg | Drug | Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg to 15 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in body weight at week 24 | percent change in body weight | From baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in body weight (%) at week 12 and week 27 | percent change in body weight | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ctrough (the trough plasma concentration of TG103) | Ctrough will be measured once every 4 week until week 24. | From baseline to week 24 |
| Number of participants with Anti-TG103 antibodies positive | Anti-TG103 antibodies will be measured once every 4 week until week 27. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Li | Contact | 13719165213 | hfxyl@163.net | |
| Tianhao Zhang | Contact | 010-63932012 | zhangtianhao@mail.ecspc.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Li | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baotou City Central Hospital | Recruiting | Baotou | Neimenggu | 014040 | China |
There is no plan to share IPD.
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| TG103 22.5 mg | Drug | Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. Doses gradually increased from 7.5 mg, 15 mg to 22.5 mg. |
|
| Placebo | Drug | Administered subcutaneously (s.c., under the skin) as well as calorie restrict diet and increased physical activity for 24 weeks. |
|
| From baseline to week 24 |
| Change from baseline to 12 weeks, 24 weeks and 27 weeks in body weight | weight in kg | From baseline to week 27 |
| Change from baseline to 12 weeks, 24 weeks and 27 weeks in BMI | BMI in kg/m^2 | From baseline to week 27 |
| Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist to hip circumference ratio | waist circumference and hip circumference will be combined to report waist to hip circumference ratio | From baseline to week 27 |
| Change from baseline to 12 weeks, 24 weeks and 27 weeks in waist circumference | waist circumference in cm | From baseline to week 27 |
| Change from baseline to 12 weeks and 24 weeks in HbA1c | HbA1c in % | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in FPG (fasting plasma glucose) | FPG (fasting plasma glucose) in mmol/L | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in FINS (fasting insulin) | FINS (fasting insulin) in mU/L | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in fasting C peptide | fasting C peptide in nmol/L | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in HOMA-IR | FPG and FINS will be combined to report HOMA-IR in mmol/mU | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in TC（total cholesterol） | TC in mmol/L | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in TG（triglyceride） | TG in mmol/L | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in LDLC（low density lipoprotein cholesterol） | LDLC in mmol/L | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in HDLC（high density lipoprotein cholesterol） | HDLC in mmol/L | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in systolic blood pressure and diastolic blood pressure | systolic blood pressure, diastolic blood pressure in mmHg, respectively | From baseline to week 24 |
| Change from baseline to 12 weeks and 24 weeks in scores of the patient health questionnaire (PHQ-9) | There are 9 items in PHQ-9 and the score ranges from 0-3 for each item. The total score will be the sum of the scores of all items. | From baseline to week 24 |
| Number of TEAEs and SAEs from baseline to week 27 | From baseline to week 27 |
| From baseline to week 27 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |