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



Status:Recruiting
Conditions:Gastrointestinal, Gastrointestinal, Gastrointestinal, Hepatitis, Digestive Disease
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 75
Updated:3/14/2019
Start Date:November 26, 2018
End Date:October 31, 2019
Contact:S Gamble, PhD
Email:clinical.trials@hightidetx.com
Phone:301-801-8815

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Trial Summary
Trial Overview
Inclusion Criteria

A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adults With NASH and T2DM

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


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
We found this trial at
15
sites
Adobe Clinical Research, LLC
Tucson, Arizona 85712
Phone: 520-318-1236
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Compass Research LLC
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Phone: 407-426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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Univ of Washington
Seattle, Washington 98104
(206) 543-2100
Phone: 206-744-7064
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Pinnacle Clinical Research, PLLC
Austin, Texas 78746
Phone: 512-384-4560
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Austin, TX
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Excel Medical Clinical Trials, LLC
Boca Raton, Florida 33434
Phone: 561-756-8206
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Boca Raton, FL
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The Institute for Liver Health
1955 West Frye Road
Chandler, Arizona 85224
Phone: 480-686-8874
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Chandler, AZ
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Doctors Hospital At Renaissance
Edinburg, Texas 78539
Phone: 956-362-2381
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Edinburg, TX
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Cumberland Research Associates
Fayetteville, North Carolina 28304
Phone: 910-484-8163
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Fayetteville, NC
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Gastro One
Germantown, Tennessee 38138
Phone: 901-682-2450
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Germantown, TN
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Digestive Health Research
5653 Frist Boulevard
Hermitage, Tennessee 37076
Phone: 615-499-4740
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Hermitage, TN
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Kansas City Research Institute
425 Volker Boulevard
Kansas City, Missouri 64131
Phone: 816-759-5274
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Kansas City, MO
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Florida Research Institute
Lakewood Ranch, Florida 34211
Phone: 941-727-7772
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Lakewood Ranch, FL
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National Research Institute
2010 Wilshire Boulevard
Panorama City, California 91402
Phone: 818-532-6880
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Panorama City, CA
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Pinnacle Clinical Research
San Antonio, Texas 78265
Phone: 210-982-0320
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San Antonio, TX
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Institute for Liver Health
Tucson, Arizona 85711
Phone: 480-686-8874
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Tucson, AZ
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