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COMPLETED Phase 2

Phase 2b Study in NASH to Assess IVA337

NCT03008070 · View on ClinicalTrials.gov ↗

Study Summary

Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA337 (lanifibranor) is a next generation pan-PPAR (peroxisome proliferator-activated receptors) agonist addressing the pathophysiology of NASH : metabolic, inflammatory and fibrotic. The purpose of this research is to evaluate the efficacy and the safety of two doses of IVA337 (800mg, 1200 mg) per day for 24 weeks versus placebo in adult NASH patients with liver steatosis and moderate to severe necroinflammation without cirrhosis.

Interventions

  • DRUG Placebo
  • DRUG IVA337

Study Locations (20)

Other

  • Flinders Medical Centre Department of Hepatology — Bedford Park
  • Monash Medical Centre — Clayton
  • Lyell McEwin Hospital & The University of Adelaide — Elizabeth Vale
  • Royal Brisbane and Women's Hospital — Herston
  • Fiona Stanley Hospital — Murdoch
  • Medical University Vienna — Vienna

California

  • ACTRI — La Jolla
  • National Research Institute — Los Angeles

Florida

  • Palmetto Research, LLC — Hialeah
  • Florida Digestive Health Specialists, LLP — Lakewood Rch

North Carolina

  • Duke University Medical Center — Durham
  • Carolina's Center for Liver Disease/CHG — Huntersville

Texas

  • The Texas Liver Institute — San Antonio
  • Digestive Health Research, LLC — San Antonio

Virginia

  • University of Virginia Health System — Charlottesville
  • Virginia Commonwealth University — Richmond

Alabama

  • North Alabama GI Research Center — Madison

Massachusetts

  • Northeast GI Research Division — Concord

Trial Details

FieldValue
Enrollment Target 247 participants
Start Date 2017-02-07
Est. Completion 2020-03-16
Phase Phase 2

Sponsor

Inventiva Pharma

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03008070

The ClinicalTrials.gov registry entry for NCT03008070 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 247 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Inventiva Pharma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03008070 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03008070 about?

NCT03008070 is a clinical study titled "Phase 2b Study in NASH to Assess IVA337". Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common. However, Treatment of NASH is a significant unmet clinical need. IVA33...

What is the current status of trial NCT03008070?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 247 participants. The study started on 2017-02-07. Estimated completion is 2020-03-16.

What conditions does trial NCT03008070 study?

This clinical trial studies the following conditions: Non-Alcoholic Steatohepatitis (NASH). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03008070?

The interventions under investigation include: Placebo (DRUG), IVA337 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03008070?

This trial is sponsored by Inventiva Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03008070 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

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