Considerations for submissions to the Novo Nordisk, Inc. (NNI) Investigator-Sponsored Studies (ISS) Program:

  • We accept protocols aligned to the Areas of Interest listed below. Protocols outside the Areas of Interest are also accepted, but are not as likely to be awarded.
  • Please review the FAQ section for additional information
  • Please review and utilize the NNI ISS protocol template located in the online system (inRich). Links can be found in the “Submit your ISS” section

  • Oral semaglutide 25mg (commercial supply only)
    • open-label only, no matched placebo
  • Semaglutide s.c. (7.2 mg)
    • open-label
    • blinded with matched placebo
  • Insulin Icodec, once-weekly
    • open-label only, no matched placebo
  • Cagrilintide 2.4mg-Semaglutide 2.4mg s.c.
    • open-label, no matched placebo
    • blinded with matched placebo
    • Semaglutide monotherapy (and/or semaglutide matched placebo) can be requested in conjunction with cagrilintide-semaglutide (and/or matched placebo).
    • No cagrilintide monotherapy is available

Cardiovascular Disease Studies

  • 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., HFrEF and HFpEF)
  • Acute myocardial infarction (AMI)


Systemic inflammation:

  • 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

 

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