The Novo Nordisk Inc. (NNI) Investigator Sponsored Studies (ISS) Program will accept protocols within our current areas of interest (AOI) as noted below. This is a competitive process. Incomplete submissions or protocols that are not within the scope of these AOIs/have low relevance to the therapeutic area may be rejected without further review. Submissions will be reviewed by the Novo Nordisk teams on both the US (NNI) and Global level. Decisions will be made based on scientific merit and strategic fit. Please review the submission requirements and abide by the timelines as outlined below.  The program requests that investigators specify how they will support enrollment of diverse populations in the study.

  • Non-invasive solutions
  • Diagnosis of MASH utilizing existing non-invasive tests
  • Diagnosis of MASH using existing clinical care pathways
  • Non-invasive tests and MASH outcomes

Transplantation:

  • Donor management
  • Pre-peri transplantation
  • Post-transplantation
  • Studies that overlap with completed, ongoing or planned research
  • Metabolic dysfunction associated steatotic liver disease (MASLD) only population

Once-Weekly Semaglutide (s.c.) - Please note that all new clinical ISS applications requesting oral Semaglutide are currently on pause and not being accepted.

  • Steatotic liver disease
    - Sarcopenia
    - Body composition
  • Alcoholic liver disease
  • Lean MASH
  • Liver histology
    - Clinical outcomes as a function of change liver histology
  • MASH
    - Natural history
    - Histology resulting in change in clinical outcomes
       - Also, in under-represented populations

Transplantation

  • Donor management
  • pre-peri transplantation
  • post-transplantation
  • Studies that overlap with completed, ongoing or planned research
  • Metabolic dysfunction associated steatotic liver disease (MASLD) only population

Once-Weekly Semaglutide (s.c.) - Please note that all new clinical ISS applications requesting oral Semaglutide are currently on pause and not being accepted.

  • Protocol
  • Detailed line-item budget
  • Principal Investigator CV
  • Active medical license (e.g., if requesting study drug)
  • Conflict of Interest form