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Trial record 1 of 1 for:    NCT04686994
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Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects

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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.

Study Description
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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 .

Condition or disease Intervention/treatment Phase
Overweight and Obesity NAFLD Hyperlipidemia Drug: ASC 41 Drug: ASC 41 Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment 3:1 ratio
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 22, 2020
Actual Primary Completion Date : January 19, 2021
Actual Study Completion Date : February 7, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Cmax of ASC41 [ Time Frame: Up to 28 days ]
    Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.

  3. 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.

  4. CL/F of ASC41 [ Time Frame: Up to 28 days ]
    Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.

  5. Vd/F of ASC41 [ Time Frame: Up to 28 days ]
    Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.

  6. 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.

  7. 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.) .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686994


Locations
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China, Hunan
Hunan provincial people's hospital
Changsha, Hunan, China
Sponsors and Collaborators
Gannex Pharma Co., Ltd.
Hunan Provincial People's Hospital
More Information
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Responsible Party: Gannex Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT04686994    
Other Study ID Numbers: ASC41-104
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gannex Pharma Co., Ltd.:
Overweight and Obesity
NAFLD
Hyperlipidemia
LDL-C
NASH
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Overweight
Body Weight
 Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases