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
Liver Health Studies
  • 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


Cagrilintide/Semaglutide Studies

  • Mechanism of action/Quality of weight loss:
    • Bone health/preservation
    • Muscle health – muscle function
    • Physical function
    • Energy intake
  • The lived treatment experience:
    • Food noise
  • Obesity Related Complications:
    • Metabolic dysfunction-associated steatohepatitis (MASH)
    • Hypertension
  • Women’s & Men’s Health:
    • Stress Urinary Incontinence
    • Polycystic Ovary Syndrome (PCOS)
    • Menopause
    • Erectile Dysfunction
    • Male Hypogonadism
  • Studies that overlap with completed, ongoing or planned research
  • Metabolic dysfunction associated steatotic liver disease (MASLD) only population
  • Studies that overlap with completed, ongoing or planned research (Find Study Results)

  • 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 (Find Study Results)
  • 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