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| ID | Type | Description | Link |
|---|---|---|---|
| YN011-W201 | Other Identifier | Guangzhou Innogen Pharmaceutical Group Co., Ltd. |
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| Name | Class |
|---|---|
| Shanghai Jiao Tong University Affiliated Sixth People's Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Jinan Central Hospital | OTHER |
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This is a study to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of Efsubaglutide Alfa at difference dose range once-weekly in patients with Overweight or Obesity.
This study will look at the adverse events and the change in participants' body weight from the start of the study to the end. Weight loss in participants taking Efsubaglutide Alfa will be compared to weight loss in participants taking placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Efsubaglutide Alfa 5mg | Experimental | 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo. |
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| Efsubaglutide Alfa 7.5mg | Experimental | 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 4 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 7.5 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo. |
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| Efsubaglutide Alfa 10mg | Experimental | 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 6 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo. |
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| Efsubaglutide Alfa 15mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efsubaglutide Alfa | Biological | Efsubaglutide Alfa subcutaneous injection under 1mg, 3mg, 5mg, 7.5mg, 10mg, 15mg or 20mg dose weekly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight | Relative Change in Body Weight (%), Proportion of subjects with a weight loss of ≥5% from baseline | Baseline, 4 weeks after the target dose |
| Adverse Event | Numbers of Adverse Event | Adverse events occurring within 4 weeks of the last dose from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Proportion of subjects with a weight loss of ≥10% or ≥15% from baseline, Change from baseline in weight | Baseline, 4 weeks after the target dose |
| BMI | Change from baseline in BMI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiping Jia, M.D,Ph. D | Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Beijing | China | China | |||
| Jinan Central Hospital Affiliated to Shandong First Medical University |
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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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10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa or Placebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 8 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo. |
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| Efsubaglutide Alfa 20mg | Experimental | 10 eligible subjects will be randomized in a 8:2 manner to receive either Efsubaglutide Alfa orPlacebo, Dose escalation of Efsubaglutide Alfa or Placebo should take place during the first 12 weeks after randomization as describe in detail description. All subjects should aim at reaching the recommended target dose of Efsubaglutide Alfa 10 mg once-weekly maintenances 4 weeks or the corresponding volume of Placebo. |
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| Placebo | Other | Placebo subcutaneous injection weekly |
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| Baseline, 4 weeks after the target dose |
| Waist circumference | Change from baseline in Waist circumference | Baseline, 4 weeks after the target dose |
| Hip circumference | Change from baseline in Hip circumference | Baseline, 4 weeks after the target dose |
| Waist Hip Rate (WHR) | Change from baseline in Waist Hip Rate (WHR) | Baseline, 4 weeks after the target dose |
| Diastolic pressure | Change from baseline in Diastolic pressure | Baseline, 4 weeks after the target dose |
| Systolic pressure | Change from baseline in Systolic pressure | Baseline, 4 weeks after the target dose |
| Triglyceride | Change from baseline in Triglyceride | Baseline, 4 weeks after the target dose |
| Total Cholesterol | Change from baseline in Total Cholesterol | Baseline, 4 weeks after the target dose |
| High Density Lipoprotein Cholesterol （HDL-C） | Change from baseline in High Density Lipoprotein Cholesterol （HDL-C） | Baseline, 4 weeks after the target dose |
| Low-Density Lipoprotein Cholesterol （LDL-C） | Change from baseline in Low-Density Lipoprotein Cholesterol （LDL-C） | Baseline, 4 weeks after the target dose |
| HbA1c | Change from baseline in HbA1c | Baseline, 4 weeks after the target dose |
| Fasting Blood Insulin | Change from baseline in Fasting Blood Insulin | Baseline, 4 weeks after the target dose |
| HOMA-IR | Change from baseline in HOMA-IR | Baseline, 4 weeks after the target dose |
| Body Fat | Change in body fat from baseline measured with a body fat scale. | Baseline, 4 weeks after the target dose |
| Jinan |
| China |
| China |
| Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University | Shanghai | China | 200030 | China |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |