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A Phase 2b Study of Icosabutate in Fatty Liver Disease

NCT04052516 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2025-02-28

Study results available
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Summary

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

Conditions

  • Non Alcoholic Steatohepatitis (NASH)

Interventions

DRUG

Icosabutate

Icosabutate oral capsule once daily

DRUG

Placebo

Matching placebo oral capsule

Sponsors & Collaborators

  • NorthSea Therapeutics B.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-17
Primary Completion
2022-02-20
Completion
2022-12-19
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04052516 on ClinicalTrials.gov