At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
Leu-Met-Sil 0.5 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Blinded, Placebo-Controlled Study To Evaluate The Effect Fixed-Dose Leucine, Metformin, Sildenafil Combinations(NS-0200) Versus Placebo On Hepatic Fat Assessed By MRI In Non Alcoholic Fatty Liver Disease Patients
In Brief
A Phase 2 clinical trial evaluating Leu-Met-Sil 0.5, Leu-Met-Sil 1.0, and 1 other intervention for NAFLD. Completed, enrolled 91 participants across 13 sites.
Detailed Summary
The goal of this study is to determine if NS-0200 can reduce the amount of liver fat in patients diagnosed with non-alcoholic fatty liver disease (NAFLD). This study will compare two doses of NS-0200 to placebo in NAFLD patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNAFLD
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2015
Enrollment StartNov 2015
Primary CompletionNov 2016
Study CompletionJan 2017
TodayJul 2026
First PostedSep 11, 2015
Enrollment StartNov 19, 2015
Primary CompletionNov 30, 2016
Study CompletionJan 31, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.8 years ago
Interventions
Leu-Met-Sil 0.5drug
NS-0200 low dose
Leu-Met-Sil 1.0drug
NS-200 high dose
Placebodrug
Placebo