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

Overweight and Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686994
• Other study ID #: ASC41-104
• Status: Completed
• Phase: Phase 1
• Start date: December 22, 2020
• Est. completion date: February 7, 2021

Study information

• Verified date: December 2020
• Source: Gannex Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 7, 2021
• Est. primary completion date: January 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• NAFLD
• Overweight
• Overweight and Obesity

Intervention

Drug:
• ASC 41
Oral tablets
• ASC 41 Placebo
Oral tablets

Locations

Country	Name	City	State
China	Hunan provincial people's hospital	Changsha	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.	Hunan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	AUC of ASC41	Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.	Up to 28 days
Secondary	Cmax of ASC41	Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.	Up to 28 days
Secondary	t1/2 of ASC41	Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.	Up to 28 days
Secondary	CL/F of ASC41	Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.	Up to 28 days
Secondary	Vd/F of ASC41	Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.	Up to 28 days
Secondary	Tmax of ASC41	Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.	Up to 28 days
Secondary	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