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

September 25, 2024 updated by: Gannex Pharma Co., Ltd.

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China
        • Hunan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 28 days
Cmax of ASC41
Time Frame: Up to 28 days
Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.
Up to 28 days
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.
Up to 28 days
CL/F of ASC41
Time Frame: Up to 28 days
Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Up to 28 days
Vd/F of ASC41
Time Frame: Up to 28 days
Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
Up to 28 days
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.
Up to 28 days
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.) .
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gannex Pharma Co., Ltd.

Collaborators

Hunan Provincial People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2020

Primary Completion (Actual)

January 19, 2021

Study Completion (Actual)

February 7, 2021

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC41-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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