Phase 2b Study in NASH to Assess IVA337
Public ClinicalTrials.gov record NCT03008070. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Dose-range, Proof-of-concept, 24-week Treatment Study of IVA337 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03008070
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 247 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 6, 2017
- Primary completion
- Feb 19, 2020
- Completion
- Mar 15, 2020
- Last update posted
- Jul 18, 2023
2017 – 2020
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Alabama GI Research Center | Madison | Alabama | 35758 | — |
| ACTRI | La Jolla | California | 92037 | — |
| National Research Institute | Los Angeles | California | 90057 | — |
| Palmetto Research, LLC | Hialeah | Florida | 33016 | — |
| Florida Digestive Health Specialists, LLP | Lakewood Rch | Florida | 34211 | — |
| Northeast GI Research Division | Concord | Massachusetts | 29027 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Carolina's Center for Liver Disease/CHG | Huntersville | North Carolina | 28078 | — |
| Jefferson University hospital | Philadelphia | Pennsylvania | 19107 | — |
| Digestive Health Research, LLC | Hermitage | Tennessee | 37076 | — |
| The Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Digestive Health Research, LLC | San Antonio | Texas | 78229 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03008070, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 18, 2023 · Synced Sep 24, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03008070 live on ClinicalTrials.gov.