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A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

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ClinicalTrials.gov Identifier: NCT03656744
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
HighTide Biopharma Pty Ltd

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE September 4, 2018
Last Update Posted Date February 16, 2021
Actual Study Start Date  ICMJE November 26, 2018
Actual Primary Completion Date February 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Change in liver fat content (LFC) as measured by Magnetic Resonance Imaging (MRI) [ Time Frame: 18 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2019)
  • Proportion of subjects who achieve a reduction in LFC as measured by MRI [ Time Frame: 18 weeks ]
  • Changes in Glucose [ Time Frame: 18 weeks ]
  • Changes in Hemoglobin A1c [ Time Frame: 18 weeks ]
  • Changes in low-density lipoprotein cholesterol (LDL-c) [ Time Frame: 18 weeks ]
  • Changes in alanine aminotransferase (ALT) [ Time Frame: 18 weeks ]
  • Changes in aspartate aminotransferase (AST) [ Time Frame: 18 weeks ]
  • Changes in Pro-C3 [ Time Frame: 18 weeks ]
  • Changes in enhanced liver fibrosis (ELF) score [ Time Frame: 18 weeks ]
  • Changes in bile acids [ Time Frame: 18 weeks ]
  • Frequency and severity of adverse events [ Time Frame: 18 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Proportion of subjects who achieve a reduction in LFC as measured by MRI [ Time Frame: 18 weeks ]
  • Changes in Glucose [ Time Frame: 18 weeks ]
  • Changes in Hemoglobin A1c [ Time Frame: 18 weeks ]
  • Changes in low-density lipoprotein cholesterol (LDL-c) [ Time Frame: 18 weeks ]
  • Changes in ALT [ Time Frame: 18 weeks ]
  • Changes in AST [ Time Frame: 18 weeks ]
  • Frequency and severity of adverse events [ Time Frame: 18 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
Official Title  ICMJE A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM
Brief Summary Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Fatty Liver, Nonalcoholic
  • NAFLD
  • Nonalcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis
  • Digestive System Diseases
  • Type 2 Diabetes Mellitus (T2DM)
Intervention  ICMJE
  • Drug: HTD1801
    HTD1801 tablets, 250mg
  • Drug: Placebo
    tablets manufactured to mimic HTD1801 tablets
Study Arms  ICMJE
  • Experimental: 500mg HTD1801, bid
    Intervention: Drug: HTD1801
  • Experimental: 1000mg HTD1801, bid
    Intervention: Drug: HTD1801
  • Placebo Comparator: placebo, bid
    Intervention: Drug: 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: October 23, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
117
Actual Study Completion Date  ICMJE March 9, 2020
Actual Primary Completion Date February 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of NASH as assessed by MRI
  • Clinically documented diagnosis of T2DM
  • Body mass index (BMI) >25 kg/m2

Exclusion Criteria:

  • Liver disease unrelated to NASH
  • Poorly controlled T2DM or Type 1 Diabetes Mellitus
  • History of alcohol or substance abuse or dependence
  • Inability to undergo MRI for any reason
  • History of significant cardiovascular disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03656744
Other Study ID Numbers  ICMJE HTD1801.PCT012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party HighTide Biopharma Pty Ltd
Study Sponsor  ICMJE HighTide Biopharma Pty Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Adrian Di Bisceglie, MD,FACP,FAASLD HighTide Therapeutics USA, LLC
PRS Account HighTide Biopharma Pty Ltd
Verification Date February 2021

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