The Effect Of NS-0200 Versus Placebo On Hepatic Fat Content In Patients With Non Alcoholic Fatty Liver Disease

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.

Timeline

Start

2015-11-19

Primary completion

2016-11-30

Completion

2017-01-31

Outcome

Missed primary endpoint

registry analysis (other test); Placebo vs Leu Met Sil 0.5mg; p = 0.0572; ANCOVA NCT02546609 ↗

registry analysis (other test); Placebo vs Leu Met Sil 1.0mg; p = 0.3770; ANCOVA NCT02546609 ↗

Publications

• Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1.
• Zemel MB, Kolterman O, Rinella M, Vuppalanchi R, Flores O, Barritt AS 4th, Siddiqui M, Chalasani N. Randomized Controlled Trial of a Leucine-Metformin-Sildenafil Combination (NS-0200) on Weight and Metabolic Parameters. Obesity (Silver Spring). 2019 Jan;27(1):59-67. doi: 10.1002/oby.22346.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metformin	Small molecule	0.5 g	—
Subject	Sildenafil	Unknown	0.5 mg	—
Subject	Sildenafil	Unknown	1 mg	—
Subject	leucine	Small molecule	1.1 g	—

Indications