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

Obesity Studies

  • Women’s health
    • Menopause-related symptoms
    • Sarcopenic obesity
    • Obesity-related Polycystic Ovary Syndrome (PCOS)
  • Male hypogonadism (i.e., low libido, erectile dysfunction)
  • Obstructive Sleep apnea
  • Semaglutide-induced weight loss with ad libitum eating
  • Weight loss maintenance
    • Dose & frequency flexibility (e.g., drug holiday, time on/off)
  • Drug switching between anti-obesity medications
  • Effects of intentional weight loss on body composition related to:
    • Muscle function and quality
    • Bone health
  • Effects of GLP1 on gastric emptying
  • Cancer primary and secondary prevention

 

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 (Find Study Results)
  • Post-bariatric surgery use of semaglutide

Obesity subpopulation:

  • Populations disproportionately affected by obesity

Obesity-related comorbidities including but not limited to:

  • Cancer (e.g., pathophysiology, outcomes, risk, remission etc.)
  • Atherosclerotic cardiovascular disease (ASCVD)

Obesity in relation to:

  • Primary prevention of disease with intentional weight loss
  • Obesity pathophysiology (e.g., metabolic adaptation) and body composition

Other:

  • Studies not in conflict with ongoing NN research

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