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

Completed · Phase 2 · Has a placebo group

Conditions studied: Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Digestive System Diseases, Type 2 Diabetes Mellitus (T2DM)

In brief

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

Key facts

Study ID

NCT03656744

Run by

HighTide Biopharma Pty Ltd

People needed

101

Starts

2018-11-26

Expected to finish

2020-03-09

Last updated by the study team

2021-12-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Institute for Liver Health — Chandler, Arizona, United States
• Institute for Liver Health — Tucson, Arizona, United States
• Adobe Clinical Research — Tucson, Arizona, United States
• National Research Institute — Panorama City, California, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• Compass Research — Orlando, Florida, United States
• Kansas City Research Institute — Kansas City, Missouri, United States
• Cumberland Research Associates — Fayetteville, North Carolina, United States
• Gastro One — Germantown, Tennessee, United States
• Digestive Health Research — Hermitage, Tennessee, United States
• Pinnacle Clinical Research — Austin, Texas, United States
• Doctors Hospital at Renaissance — Edinburg, Texas, United States
• Pinnacle Clinical Research — San Antonio, Texas, United States
• Texas Digestive Disease Consultants — Southlake, Texas, United States
• Harborview Medical Center — Seattle, Washington, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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