Clinical Trials Logo

Clinical Trial Summary

A Randomized, Controlled, Double-blind, Parallel Group, Single Center Phase 2 Clinical Trial to Evaluate Multiple Non-Invasive Liver Fibrosis Imaging Methods in the Assessment of the Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis in Patients with NASH with Advanced Fibrosis


Clinical Trial Description

The primary objective is to determine the difference between placebo and GR-MD-02 treatment in the baseline adjusted mean change in liver fibrosis as measured by corrected T1 (cT1) mapping as determined from LiverMultiScan (LMS), a multi-parametric MRI protocol.

Secondary objectives include evaluating differences between subjects treated with GR-MD-02 versus placebo in:

- The baseline-adjusted change in liver stiffness as measured by MR-elastography

- The baseline-adjusted change in liver stiffness as measured by FibroScan® scores.

An exploratory objective will be to evaluate the correlation of the three diagnostic modalities of LiverMultiScan, MR-Elastography, and FibroScan®. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02421094
Study type Interventional
Source Galectin Therapeutics Inc.
Contact
Status Completed
Phase Phase 2
Start date September 2015
Completion date September 27, 2016

See also
  Status Clinical Trial Phase
Completed NCT03375008 - Predictable MR Index for Nonalcoholic Steatohepatitis (NASH) N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Phase 2
Withdrawn NCT02769091 - A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes Phase 2
Completed NCT02654977 - CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy Phase 2
Recruiting NCT05211284 - Saroglitazar Magnesium 4 mg for NASH in People Living With HIV in the US Phase 2
Completed NCT01205087 - Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome Phase 2
Recruiting NCT00152711 - Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis N/A
Completed NCT02217475 - Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis Phase 2
Completed NCT04031729 - Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease Phase 1/Phase 2
Completed NCT03674476 - An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function Phase 1
Recruiting NCT03725631 - Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD N/A
Terminated NCT04565717 - A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH) Phase 1
Completed NCT01679197 - Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy Phase 2
Active, not recruiting NCT05084404 - Efficacy and Safety of Guanabenz for Nonalcoholic Fatty Liver Disease Phase 2
Active, not recruiting NCT02574325 - A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis Phase 2
Terminated NCT00878592 - Effect of Dietary and Life Style Modification on Post Liver Transplant Obesity N/A
Recruiting NCT02148471 - Fatty Acids, Genes and Microbiota in Fatty Liver N/A
Completed NCT00227110 - Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH) Phase 4
Completed NCT03656744 - A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM) Phase 2
Completed NCT03068078 - A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes N/A