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

Diabetes Studies

  • Metabolic syndrome and prediabetes 
  • Prevention of T2DM/prediabetes and conversion of prediabetes to normoglycemia
  • Use of Semaglutide as standard of care
    • With weight loss or change in BMI NOT being the primary endpoint
    • Demonstration of either maintenance or improvement of functional strength/status (e.g., grip strength, sit-to-stand)
  • Body composition and bone health
    • Nutrition and exercise program in addition to Semaglutide related to change in bone health and composition
    • Treatment/Care delivery that includes 3 components: nutrition, exercise, semaglutide
  • Polycystic ovary syndrome (PCOS)
  • Weight loss as the primary endpoint/outcome
  • Type 1 Diabetes
  • Studies that overlap with completed, ongoing or planned research (Find Study Results)

Studies investigating:

  • Time in range (TIR), Time in Tight Range (TITR), other continuous glucose monitoring (CGM) parameters
  • Impact of early tight glycemic control
  • Disease modification in Type 2 diabetes T2D (e.g., defining, implementing etc.)
  • Transition from living with pre-diabetes to (T2D) 
  • 4 pillars of therapy for chronic kidney disease (CKD)
  • Durability of semaglutide on maintaining glycaemic control in the long-term, delaying the need for intensification of therapy

Subpopulations including but not limited to:

  • Type 1 diabetes
  • Adolescents
  • Ethnic/minority populations
  • History of Gestational diabetes mellitus
  • Hospitalized patients
  • Elderly/geriatric
  • Studies that overlap with completed, ongoing or planned research
  • Weight as the primary outcome
  • Peripheral artery disease (PAD) and long-term outcomes
  • Studies that overlap with completed, ongoing or planned research (Find Study Results)

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