At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 280 enrolled
Drug / intervention
Icosabutate +1 moredrug
Likely dose
Icosabutate oral capsule once dailyAI-extracted
Key inclusion· 5
- ✓Age 18 to 75 years
- ✓Histologically confirmed NASH diagnosis prior to study entry
- ✓NAS (NAFLD Activity Score) ≥4 with at least 1 point in each of steatosis, lobular inflammation, and ballooning
- ✓Fibrosis stage F1-F3 (F1 capped at 30%)
Key exclusion· 8
- ✕History of alcohol abuse or daily heavy alcohol consumption
- ✕Bariatric surgery within the past 5 years
- ✕Significant systemic or major illnesses other than liver disease
- ✕Recent (within 6 months) cardiac dysrhythmias and/or cardiovascular disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of NST-4016 in Patients With Nonalcoholic Steatohepatitis (NASH)
In Brief
A Phase 2 clinical trial evaluating Icosabutate and Placebo for Non Alcoholic Steatohepatitis (NASH). Completed, enrolled 280 participants across 39 sites in 2 countries.
Detailed Summary
A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Alcoholic Steatohepatitis (NASH)
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartJul 2019
First PostedAug 2019
Primary CompletionFeb 2022
Study CompletionDec 2022
TodayJul 2026
First PostedAug 9, 2019
Enrollment StartJul 17, 2019
Primary CompletionFeb 20, 2022
Study CompletionDec 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.9 years ago
Interventions
Icosabutatedrug
Icosabutate oral capsule once daily
Placebodrug
Matching placebo oral capsule