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NCT04052516 · ClinicalTrials.gov registry record · Phase 2

A Phase 2b Study of Icosabutate in Fatty Liver Disease

A Phase 2 study of Non-alcoholic Steatohepatitis (NASH), sponsored by NorthSea Therapeutics B.V..

Completed
Registry status
Phase 2
Development phase
280
Enrollment target
20
Study locations

NCT04052516 is a Phase 2 study of Non-alcoholic Steatohepatitis (NASH) that has completed, run by NorthSea Therapeutics B.V.. The registered enrollment target is 280 participants, above the 137-participant average among 8 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (104% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT04052516, a Phase 2 study of Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by NorthSea Therapeutics B.V..

COMPLETED
Registry status
Phase 2
Development phase
280 participants
Enrollment target
20
Study locations

Study Summary

A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis

Interventions

  • DRUG Placebo
  • DRUG Icosabutate

Study Locations (20)

California

  • Fresno Clinical Research Center - Fresno
  • National Research Institute - Huntington Park - Huntington Park
  • National Research Institute - Wilshire - Los Angeles
  • National Research Institute - Panorama - Panorama City
  • Alliance Clinical Research - Poway
  • National Research Institute - Santa Ana - Santa Ana

Arizona

  • Arizona Liver Health - Chandler
  • Arizona Liver Health - Glendale - Glendale
  • Arizona Liver Health - Tucson
  • Adobe Clinical Research, LLC - Tucson

Florida

  • Excel Medical Clinical Trials, LLC - Boca Raton
  • Sensible Healthcare LLC - Ocoee
  • Covenant Research LLC - Sarasota

Louisiana

  • Texas Digestive Disease Consultants - Baton Rouge
  • Tandem Clinical Research - Marrero

Alabama

  • Central ResearchAssociates Inc. - Birmingham

Arkansas

  • Arkansas Gastroenterology - North Little Rock - North Little Rock

Colorado

  • South Denver Gastroenterology - Englewood

Georgia

  • Gastrointestinal Specialists of Georgia PC - Marietta

Trial Details

FieldValue
Enrollment Target 280 participants
Start Date 2019-07-17
Est. Completion 2022-12-19
Phase Phase 2

Sponsor

NorthSea Therapeutics B.V.

3 total trials

What the Registry Record Tells You About NCT04052516

The ClinicalTrials.gov registry entry for NCT04052516 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 137-participant average among 8 other Non-alcoholic Steatohepatitis (NASH) trials with a reported enrollment target (104% higher). The listed sponsor is NorthSea Therapeutics B.V., which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-alcoholic Steatohepatitis (NASH) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04052516 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT04052516 about?

NCT04052516 is a clinical study titled "A Phase 2b Study of Icosabutate in Fatty Liver Disease". A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis

What is the current status of trial NCT04052516?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 280 participants. The study started on 2019-07-17. Estimated completion is 2022-12-19.

What conditions does trial NCT04052516 study?

This clinical trial studies the following conditions: Non-alcoholic Steatohepatitis (NASH).

What interventions are being tested in trial NCT04052516?

The interventions under investigation include: Placebo (DRUG), Icosabutate (DRUG).

Who is sponsoring clinical trial NCT04052516?

This trial is sponsored by NorthSea Therapeutics B.V., which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04052516 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.