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

Phase 1

Completed

• Conditions: Overweight and Obesity; NAFLD; Hyperlipidemia
• Interventions: Drug: ASC 41; Drug: ASC 41 Placebo

• Registration Number: NCT04686994
• Lead Sponsor: Gannex Pharma Co., Ltd.

Brief Summary

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-22
• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Primary Completion: 2021-01-19
• Study Completion: 2021-02-07
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 23kg/m2 ≤ BMI <40kg/m2.

Key

Exclusion Criteria

• A history of thyroid disease.
• A positive HBsAg, HCV Ab and/or HIV Ab.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASC41	ASC 41	ASC41 two tablets, once daily, from Day 1 to Day 28.
ASC41 placebo	ASC 41 Placebo	ASC41 placebo two tablets, once daily, from Day 1 to Day 28.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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

Secondary Outcome Measures

Name	Time	Method
LDL-C and other lipid parameters	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.) .
AUC of ASC41	Up to 28 days	Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.
Cmax of ASC41	Up to 28 days	Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.
t1/2 of ASC41	Up to 28 days	Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.
Vd/F of ASC41	Up to 28 days	Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
CL/F of ASC41	Up to 28 days	Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Tmax of ASC41	Up to 28 days	Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.

Trial Locations

Locations (1)

Hunan provincial people's hospital; 🇨🇳 Changsha, Hunan, China