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

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

Brief Summary:
Randomized, double-blind, placebo-controlled, parallel-group study comparing multiple doses of HTD1801 to placebo.

Condition or disease Intervention/treatment Phase
Fatty Liver, Nonalcoholic NAFLD Nonalcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Digestive System Diseases Type 2 Diabetes Mellitus (T2DM) Drug: HTD1801 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM
Actual Study Start Date : November 26, 2018
Actual Primary Completion Date : February 7, 2020
Actual Study Completion Date : March 9, 2020

Arm Intervention/treatment
Experimental: 500mg HTD1801, bid Drug: HTD1801
HTD1801 tablets, 250mg

Experimental: 1000mg HTD1801, bid Drug: HTD1801
HTD1801 tablets, 250mg

Placebo Comparator: placebo, bid Drug: Placebo
tablets manufactured to mimic HTD1801 tablets

Primary Outcome Measures :
  1. Change in liver fat content (LFC) as measured by Magnetic Resonance Imaging (MRI) [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects who achieve a reduction in LFC as measured by MRI [ Time Frame: 18 weeks ]
  2. Changes in glucose [ Time Frame: 18 weeks ]
  3. Changes in hemoglobin A1c [ Time Frame: 18 weeks ]
  4. Changes in low-density lipoprotein cholesterol (LDL-c) [ Time Frame: 18 weeks ]
  5. Changes in alanine aminotransferase (ALT) [ Time Frame: 18 weeks ]
  6. Changes in aspartate aminotransferase (AST) [ Time Frame: 18 weeks ]
  7. Changes in Pro-C3 [ Time Frame: 18 weeks ]
  8. Changes in enhanced liver fibrosis (ELF) score [ Time Frame: 18 weeks ]
  9. Changes in bile acids [ Time Frame: 18 weeks ]
  10. Frequency and severity of adverse events [ Time Frame: 18 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03656744

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United States, Arizona
Institute for Liver Health
Chandler, Arizona, United States, 85224
Institute for Liver Health
Tucson, Arizona, United States, 85711
Adobe Clinical Research
Tucson, Arizona, United States, 85712
United States, California
National Research Institute
Panorama City, California, United States, 91402
United States, Florida
Excel Medical Clinical Trials
Boca Raton, Florida, United States, 33434
Florida Research Institute
Lakewood Ranch, Florida, United States, 34211
Compass Research
Orlando, Florida, United States, 32806
United States, Missouri
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
United States, North Carolina
Cumberland Research Associates
Fayetteville, North Carolina, United States, 28304
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
Digestive Health Research
Hermitage, Tennessee, United States, 37076
United States, Texas
Pinnacle Clinical Research
Austin, Texas, United States, 78746
Doctors Hospital at Renaissance
Edinburg, Texas, United States, 78539
Pinnacle Clinical Research
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants
Southlake, Texas, United States, 76092
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98195
University of Washington Medical Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
HighTide Biopharma Pty Ltd
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Study Director: Adrian Di Bisceglie, MD,FACP,FAASLD HighTide Therapeutics USA, LLC
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Responsible Party: HighTide Biopharma Pty Ltd Identifier: NCT03656744    
Other Study ID Numbers: HTD1801.PCT012
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Gastrointestinal Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases