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Trial record 84 of 6720 for:    Recruiting, Not yet recruiting, Available Studies | Digestion

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 : Recruiting
First Posted : September 3, 2018
Last Update Posted : October 11, 2019
Sponsor:
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 Drug: HTD1801 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 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
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019


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 ]


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03656744


Contacts
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Contact: S Gamble, PhD 301-801-8815 clinical.trials@hightidetx.com

Locations
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United States, Arizona
Institute for Liver Health Recruiting
Chandler, Arizona, United States, 85224
Contact: Anita Kohli, MD    480-686-8874    drkohli@iliverhealth.org   
Contact: Dana M. Robledo, MD, MBA    480-686-8874    drobledo@iliverhealth.org   
Institute for Liver Health Recruiting
Tucson, Arizona, United States, 85711
Contact: Anita Kohli, MD    480-686-8874    drkohli@iliverhealth.org   
Contact: Mario A. Gutierrez Casale, MD, MPH    520-274-1224    mgutierrez@iliverhealth.org   
Adobe Clinical Research Recruiting
Tucson, Arizona, United States, 85712
Contact: Sam E. Moussa, MD    520-318-1236    dr.moussa@adobegastroenterology.com   
Contact: Lori L. Botello, MS, CCRC    520-318-1236    lori@adobegastro.com   
United States, California
National Research Institute Recruiting
Panorama City, California, United States, 91402
Contact: Modesto Carrillo, AS    818-532-6880    modesto.carrillo@nritrials.com   
Contact: Vanessa Delgado    818-532-6880    vanessa.delgado@nritrials.com   
United States, Florida
Excel Medical Clinical Trials Recruiting
Boca Raton, Florida, United States, 33434
Contact: Seth J. Baum, MD    561-756-8206    research@emclinicaltrials.com   
Florida Research Institute Recruiting
Lakewood Ranch, Florida, United States, 34211
Contact: Tracy L. Balentine, RN, MS, CCRC    941-727-7772    tracy.balentine@fdhs.com   
Contact: Johanna Valentin, MBA    941-727-7772    johanna.valentin@fdhs.com   
Compass Research Recruiting
Orlando, Florida, United States, 32806
Contact: Judith L. White, MD, CPI    407-426-9299    judith.white@bioclinica.com   
Contact: George S. Stoica, MD, CPI    407-426-9299    george.stoica@bioclinica.com   
United States, Missouri
Kansas City Research Institute Recruiting
Kansas City, Missouri, United States, 64131
Contact: Chantell Gipson, SC    816-759-5274 ext 204    cgipson@kcresearchinstitute.com   
Contact: Kelly Vargas, SC    816-759-5274 ext 201    kvargas@kcresearchinstitute.com   
United States, North Carolina
Cumberland Research Associates Recruiting
Fayetteville, North Carolina, United States, 28304
Contact: Christina M. Steele, SC    910-484-8163    csteele@cumberlandresearchassociates.com   
Contact: Loretta Joyce, SC    910-484-8163    ljoyce@cumberlandresearchassociates.com   
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States, 38138
Contact: Alisha Bunnell, CRC    901-682-2450    abunnell@gastro1.com   
Contact: Amanda Berry, NP    901-309-6035    aberry@gastro1.com   
Digestive Health Research Recruiting
Hermitage, Tennessee, United States, 37076
Contact: Madison B. North    615-499-4740    mnorth@digestivehealthresearch.com   
Contact: Jessica Callis    615-499-4740    jcallis@digestivehealthresearch.com   
United States, Texas
Pinnacle Clinical Research Recruiting
Austin, Texas, United States, 78746
Contact: Nadege Gunn, MD    512-384-4560    ngunn@pinnacleresearch.com   
Doctors Hospital at Renaissance Recruiting
Edinburg, Texas, United States, 78539
Contact: Margaret L. Leal, MS    956-362-2381    marg.leal@dhr-rgv.com   
Contact: Rashmee Patil, MD    409-656-6475    r.patil@dhr-rgv.com   
Pinnacle Clinical Research Recruiting
San Antonio, Texas, United States, 78229
Contact: Leslie M. DeHart, MSN, FNP-C    210-982-0320 ext 1451    ldehart@pinnacleresearch.com   
Contact: Shannon Patteson, FNP-C    210-982-0320 ext 1441    spatteson@pinnacleresearch.com   
Texas Digestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
Contact: James Trotter, MD    214-323-8500    james.trotter@bswhealth.org   
Contact: Shana Westover, CCRC    469-930-3124    swestover@tddctx.com   
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Charles Landis, MD, PhD    206-744-7064    qiuw@uw.edu   
Contact: Wan Chong Qiu    206-744-7064    qiuw@uw.edu   
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Jenna Craft, BS, MPH    206-543-0826    jcraft@medicine.washington.edu   
Contact: LyTieng Huot, BA    206-221-2004    lyhuot@medicine.washington.edu   
Sponsors and Collaborators
HighTide Biopharma Pty Ltd

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Responsible Party: HighTide Biopharma Pty Ltd
ClinicalTrials.gov Identifier: NCT03656744     History of Changes
Other Study ID Numbers: HTD1801.PCT012
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
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
Gastrointestinal Diseases
Digestive System Diseases