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

Primary Purpose

Overweight and Obesity, NAFLD, Hyperlipidemia

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ASC 41
ASC 41 Placebo
Sponsored by
Gannex Pharma Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Overweight and Obesity, NAFLD, Hyperlipidemia, LDL-C, NASH

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hunan provincial people's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASC41

ASC41 placebo

Arm Description

ASC41 two tablets, once daily, from Day 1 to Day 28.

ASC41 placebo two tablets, once daily, from Day 1 to Day 28.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2020
Last Updated
April 6, 2021
Sponsor
Gannex Pharma Co., Ltd.
Collaborators
Hunan Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04686994
Brief Title
Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
January 19, 2021 (Actual)
Study Completion Date
February 7, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gannex Pharma Co., Ltd.
Collaborators
Hunan Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, NAFLD, Hyperlipidemia
Keywords
Overweight and Obesity, NAFLD, Hyperlipidemia, LDL-C, NASH

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment 3:1 ratio
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASC41
Arm Type
Experimental
Arm Description
ASC41 two tablets, once daily, from Day 1 to Day 28.
Arm Title
ASC41 placebo
Arm Type
Placebo Comparator
Arm Description
ASC41 placebo two tablets, once daily, from Day 1 to Day 28.
Intervention Type
Drug
Intervention Name(s)
ASC 41
Intervention Description
Oral tablets
Intervention Type
Drug
Intervention Name(s)
ASC 41 Placebo
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
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
Time Frame
Up to 28 days
Secondary Outcome Measure Information:
Title
AUC of ASC41
Description
Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.
Time Frame
Up to 28 days
Title
Cmax of ASC41
Description
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.
Time Frame
Up to 28 days
Title
t1/2 of ASC41
Description
Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.
Time Frame
Up to 28 days
Title
CL/F of ASC41
Description
Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Time Frame
Up to 28 days
Title
Vd/F of ASC41
Description
Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Time Frame
Up to 28 days
Title
Tmax of ASC41
Description
Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.
Time Frame
Up to 28 days
Title
LDL-C and other lipid parameters
Description
To evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) .
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hunan provincial people's hospital
City
Changsha
State/Province
Hunan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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