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| Name | Class |
|---|---|
| Hunan Provincial People's Hospital | OTHER |
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The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC41 | Experimental | ASC41 two tablets, once daily, from Day 1 to Day 28. |
|
| ASC41 placebo | Placebo Comparator | ASC41 placebo two tablets, once daily, from Day 1 to Day 28. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC 41 | Drug | Oral tablets |
| |
| ASC 41 Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 28 days | Up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of ASC41 | Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets. | Up to 28 days |
| Cmax of ASC41 | Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan provincial people's hospital | Changsha | Hunan | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Parallel Assignment 3:1 ratio
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| Drug |
Oral tablets |
|
| Up to 28 days |
| t1/2 of ASC41 | Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables. | Up to 28 days |
| CL/F of ASC41 | Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables. | Up to 28 days |
| Vd/F of ASC41 | Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables. | Up to 28 days |
| Tmax of ASC41 | Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables. | Up to 28 days |
| LDL-C and other lipid parameters | To evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) . | Up to 28 days |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |