Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects

Study Overview
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Brief Summary
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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 .

Official Title
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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

Conditions
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Overweight and Obesity, NAFLD, Hyperlipidemia

Intervention / Treatment
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* Drug: ASC 41
* Drug: ASC 41 Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 23kg/m2 ≤ BMI <40kg/m2. Key Exclusion Criteria: A history of thyroid disease. A positive HBsAg, HCV Ab and/or HIV Ab.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment 3:1 ratio
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASC41<br>ASC41 two tablets, once daily, from Day 1 to Day 28. | Drug: ASC 41<br>* Oral tablets<br>|
| Placebo Comparator: ASC41 placebo<br>ASC41 placebo two tablets, once daily, from Day 1 to Day 28. | Drug: ASC 41 Placebo<br>* Oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight and Obesity, NAFLD, Hyperlipidemia, LDL-C, NASH