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.
Areas of interest
Metabolic dysfunction associated steatohepatitis (MASH) comorbidities:
- Atherosclerosis
- Cardiovascular risk
- Cognitive function (e.g., minimal cognitive impairment, hepatic encephalopathy)
- Chronic kidney disease
- Diabetes remission
- Metabolic syndrome
- Portal venous pressure (e.g., varices, spleen size)
- Sarcopenia
Mode of Action:
- Anti-inflammatory effect
- Anti-fibrotic effect
- Body weight loss and change in body composition
Patient driven outcomes:
- Quality of life using patient reported outcomes
- Work productivity and activity impairment (WPAI)
Other:
- Liver transplantation: post liver transplantation (e.g., allograft steatosis, MASH recurrence, post transplant diabetic care)
- Precision medicine: proteomics and metabolomics, genomics and transcriptomics (at-risk population, prediction of disease progression)
- Bariatric surgery: Pre and post bariatric surgery (e.g., fibrosis regression and MASH resolution)
- Genotyping of patient populations at risk
- Non-invasive testing and endpoints (non-biopsy); indices, correlates with imaging
- Protocols not in conflict or redundant with NN research/scientific commitment in the therapeutic area
Areas not in scope:
- Studies that overlap with completed, ongoing or planned research
- Glycemic endpoints as primary endpoint
- Doses other than 2.4 mg/week
- Pregnancy & infertility
- In-vitro and animal studies
- Request for placebo only
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
March 1st 2024
May 2024
October 1st 2024
December 2024