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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686994
Recruitment Status : Completed
First Posted : December 29, 2020
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Hunan Provincial People's Hospital
Information provided by (Responsible Party):
Gannex Pharma Co., Ltd.

Tracking Information
First Submitted Date  ICMJE December 23, 2020
First Posted Date  ICMJE December 29, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE December 22, 2020
Actual Primary Completion Date January 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2020)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2020)
  • 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.
  • Cmax of ASC41 [ Time Frame: Up to 28 days ]
    Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.
  • 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.
  • CL/F of ASC41 [ Time Frame: Up to 28 days ]
    Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
  • Vd/F of ASC41 [ Time Frame: Up to 28 days ]
    Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
  • 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.
  • 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.) .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment 3:1 ratio
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Overweight and Obesity
  • NAFLD
  • Hyperlipidemia
Intervention  ICMJE
  • Drug: ASC 41
    Oral tablets
  • Drug: ASC 41 Placebo
    Oral tablets
Study Arms  ICMJE
  • Experimental: ASC41
    ASC41 two tablets, once daily, from Day 1 to Day 28.
    Intervention: Drug: ASC 41
  • Placebo Comparator: ASC41 placebo
    ASC41 placebo two tablets, once daily, from Day 1 to Day 28.
    Intervention: Drug: ASC 41 Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2020)		 20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 7, 2021
Actual Primary Completion Date January 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 59 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04686994
Other Study ID Numbers  ICMJE ASC41-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Gannex Pharma Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Gannex Pharma Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hunan Provincial People's Hospital
Investigators  ICMJE Not Provided
PRS Account Gannex Pharma Co., Ltd.
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP