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 thereaputic 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.
Please note that all new clinical ISS applications requesting semaglutide (injectables and oral formulation) are currently on pause and not being accepted.
MASH related outcomes relative to:
- Care pathways/guidelines
- Liver histology (e.g., fibrosis, steatosis, hepatocytes, ballooning etc.)
MASH Progression:
- Predictors of disease progression
- Rapid progressors vs. non-rapid progressors
- MASH diagnostic journey
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
- Studies that overlap with completed, ongoing or planned research
- Metabolic dysfunction associated steatotic liver disease (MASLD) only population
- Protocol
- Detailed line-item budget
- Principal Investigator CV
- Active medical license (e.g., if requesting study drug)
- Conflict of Interest form
October 1st 2024
December 2024
March 1st 2025
May 2025