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 oral Semaglutide are currently on pause and not being accepted

Patients with:

  • Atherosclerosis cardiovascular disease (ASCVD) + Chronic kidney disease (CKD)
  • Heart failure (e.g., HFrEF and HFpEF)
  • Acute myocardial infarction (AMI)

Outcomes related to:

  • Systemic inflammation
  • Functional outcomes in heart failure
  • Compared to other risk factors including but not limited to LDL, BP, Diabetes, Obesity
  • Other clinical biomarkers including but not limited to hsCRP, IL-6, NT-PROBNP
  • Predictors, progression over longitudinal timeframe
  • Kidney biomarkers
  • Hemoglobin biomarkers
  • Imaging characteristics of heart musculature and vasculature


Examination of hsCRP and clinical outcomes in:

  • ASCVD+CKD
  • CKD related anemia
  • Heart failure
  • Concomitant CV disorders
  • CKD only

Systemic inflammation in patients with:

  • Atherosclerosis cardiovascular disease (ASCVD) + Chronic kidney disease (CKD)
  • Heart failure (e.g., HFmrEF and HFpEF)
  • Acute myocardial infarction (AMI)


Systemic inflammation:

  • Functional outcomes in heart failure
  • Compared to other risk factors including but not limited to LDL, BP, Diabetes, Obesity
  • Other clinical biomarkers including but not limited to hsCRP, IL-6, NT-PROBNP
  • Predictors, progression over longitudinal timeframe
  • Kidney biomarkers
  • Hemoglobin biomarkers
  • Imaging characteristics of heart musculature and vasculature


Examination of hsCRP and clinical outcomes in:

  • ASCVD+CKD
  • CKD related anemia
  • Heart failure
  • Concomitant CV disorders
  • CKD only

 

  • Studies that overlap with completed, ongoing or planned research

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

Open: March 17, 2025

Closes: June 1, 2025 @ 11:59pm ET

August/September 2025