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NCT02784444 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH

A Phase 2 study of Non-alcoholic Fatty Liver Disease and NASH - Nonalcoholic Steatohepatitis, sponsored by Cirius Therapeutics.

Completed
Registry status
Phase 2
Development phase
392
Enrollment target
20
Study locations

NCT02784444 is a Phase 2 study of Non-alcoholic Fatty Liver Disease and NASH - Nonalcoholic Steatohepatitis that has completed, run by Cirius Therapeutics. The registered enrollment target is 392 participants, above the 182-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (115% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT02784444, a Phase 2 study of Non-alcoholic Fatty Liver Disease and NASH - Nonalcoholic Steatohepatitis, has completed, sponsored by Cirius Therapeutics.

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

Study Summary

This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.

Conditions Studied

Non-alcoholic Fatty Liver Disease NASH - Nonalcoholic Steatohepatitis Non-alcoholic Steatohepatitis

Interventions

  • DRUG Placebo
  • DRUG MSDC-0602K

Study Locations (20)

California

  • - Chula Vista
  • - Fresno
  • - Garden Grove
  • - Huntington Park
  • - La Mesa
  • - Los Angeles
  • - Los Angeles
  • - Poway
  • - Rialto
  • - San Diego

Florida

  • - Gainesville
  • - Hialeah
  • - Inverness
  • - Lakewood Rch
  • - Miami Lakes
  • - Wellington

Arizona

  • - Chandler
  • - Tucson

Colorado

  • - Englewood

Georgia

  • - Marietta

Trial Details

FieldValue
Enrollment Target 392 participants
Start Date 2016-09-14
Est. Completion 2019-06
Phase Phase 2

Sponsor

Cirius Therapeutics

1 total trials

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What the Registry Record Tells You About NCT02784444

The ClinicalTrials.gov registry entry for NCT02784444 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 392 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 182-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (115% higher). The listed sponsor is Cirius Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02784444 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Florida, Arizona.

Frequently Asked Questions

What is clinical trial NCT02784444 about?

NCT02784444 is a clinical study titled "A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH". This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.

What is the current status of trial NCT02784444?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 392 participants. The study started on 2016-09-14. Estimated completion is 2019-06.

What conditions does trial NCT02784444 study?

This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, NASH - Nonalcoholic Steatohepatitis, Non-alcoholic Steatohepatitis.

What interventions are being tested in trial NCT02784444?

The interventions under investigation include: Placebo (DRUG), MSDC-0602K (DRUG).

Who is sponsoring clinical trial NCT02784444?

This trial is sponsored by Cirius Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02784444 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. 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.