Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects
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|ClinicalTrials.gov Identifier: NCT04686994|
Recruitment Status : Completed
First Posted : December 29, 2020
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity NAFLD Hyperlipidemia||Drug: ASC 41 Drug: ASC 41 Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment 3:1 ratio|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC41 Tables in Overweight and Obese Subjects|
|Actual Study Start Date :||December 22, 2020|
|Actual Primary Completion Date :||January 19, 2021|
|Actual Study Completion Date :||February 7, 2021|
ASC41 two tablets, once daily, from Day 1 to Day 28.
Drug: ASC 41
Placebo Comparator: ASC41 placebo
ASC41 placebo two tablets, once daily, from Day 1 to Day 28.
Drug: ASC 41 Placebo
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 28 days ]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
- AUC of ASC41 [ Time Frame: Up to 28 days ]Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.
- Cmax of ASC41 [ Time Frame: Up to 28 days ]Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.
- t1/2 of ASC41 [ Time Frame: Up to 28 days ]Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.
- CL/F of ASC41 [ Time Frame: Up to 28 days ]Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
- Vd/F of ASC41 [ Time Frame: Up to 28 days ]Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
- Tmax of ASC41 [ Time Frame: Up to 28 days ]Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.
- LDL-C and other lipid parameters [ Time Frame: Up to 28 days ]To evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686994
|Hunan provincial people's hospital|
|Changsha, Hunan, China|