Investigator Studies Program (MISP): Non-Alcoholic SteatoHepatitis (NASH)
Effective October 2020, the NASH Investigator Studies Program (ISP) Committee will accept proposals within our current areas of interest (AOI) up to February 19, 2021 for the first review cycle, up to May 19, 2021 for the second review cycle, and up to October 13, 2021 for the third review cycle. This is a competitive process; decisions will be made on the basis of scientific merit and strategic fit within the AOI. The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.

The following areas are of interest to the Investigator Studies Program Committee:

Disease biology
  • Molecular mechanisms and novel genetic factors involved in the progression from non-alcoholic fatty liver (NAFL) to non-alcoholic steatohepatitis (NASH) and from NASH to liver cirrhosis.
  • Link between liver fat reduction and improvement of NASH; quantitative and qualitative relationship between liver fat and disease activity and fibrosis
  • Mechanisms by which changes in body weight affect NAFL and NASH

Beta-klotho/FGFR1c activation
  • Effects of activation of FGF receptors on non-alcoholic fatty liver disease (NAFLD), including NAFL and NASH; differentiation of selective FGFR1c vs non-selective FGF receptor (including FGFR4) activation
  • Mechanism of liver fat reduction by beta-klotho/FGFR1c activation
  • Targets/modes of actions (MOAs)/treatment modalities that are additive in combination with beta-klotho/FGFR1c activation for liver fat reduction and/or the treatment of NASH

GLP-1/glucagon receptor co-agonists
  • Effect of a glucagon receptor agonist in combination with a GLP-1 receptor agonist versus a GLP-1 receptor agonist alone in NAFLD
  • Direct and indirect (including weight loss-dependent and weight loss-independent) effects of glucagon on liver fat, inflammation and fibrosis

Biomarkers
  • Non-invasive biomarkers for the diagnosis of NASH
  • Non-invasive and invasive biomarkers predictive for NASH progression
  • Non-invasive and invasive biomarkers predictive for the treatment response to differing MOAs

Epidemiology
  • Epidemiologic factors such as geographic location, race/ethnicity, genetics and environmental conditions associated with progression of NAFL and NASH
  • Clinical and healthcare burden of NAFLD/NASH, globally and regionally
Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US). The proposals will be collectively reviewed and selected by the NASH MISP Committee.



MISP Information
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator Studies Program should contact their local MSD office.