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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 Nonalcoholic Steatohepatitis, sponsored by Cirius Therapeutics.

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

NCT02784444: Completed Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis, sponsored by Cirius Therapeutics.

NCT02784444 is a Phase 2 study of Non-alcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis that has completed, run by Cirius Therapeutics. The registered enrollment target is 392 participants, above the 170-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (131% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02784444, a Phase 2 study of Non-alcoholic Fatty Liver Disease and 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.

Primary Outcome

* A decrease of at least 2 points in NAS at 12 months. * At least a 1 point reduction in either ballooning or inflammation from baseline to 12 months. * no increase in CRN fibrosis score (i.e., an increase of 1 stage or more) from baseline to 12 months.

Conditions Studied

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

1 total trials

What the finished NCT02784444 record still lists

NCT02784444 is an interventional study that assigns participants to a tested intervention. The registered 392 participants enrollment target is mid-sized for trials with a published cap, above the 170-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (131% higher).

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 names 20 study sites across 5 states, led by 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, Nonalcoholic Steatohepatitis, NASH - Nonalcoholic 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.

Learn More About Clinical Trials

Similar trials for Non-alcoholic Fatty Liver Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02784444's enrollment target sits among peer trials

392 6th of 57 higher than 52 of 57 other Non-alcoholic Fatty Liver Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02784444, the US trial registry maintained by the National Library of Medicine. NCT02784444 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.