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

Metabolic syndrome and prediabetes 

Prevention of T2DM/prediabetes and conversion of prediabetes to normoglycemia

Use of Semaglutide (s.c.) as standard of care

  • By BMI category
  • With weight loss or change in BMI NOT being the primary endpoint

Body composition and bone health

  • Nutrition and exercise program in addition to Semaglutide (s.c) related to change in bone health and composition 
  • Treatment/Care delivery that includes 3 components: nutrition, exercise, Semaglutide (s.c.)

Biomarker assay

  • Validation of assay of key biomarkers or composite score 

Polycystic ovary syndrome (PCOS)

Weight loss as the primary endpoint/outcome

Type 1 Diabetes

Peripheral artery disease (PAD) and long-term outcomes:

  • 6-min walk test
  • Claudication 
  • Major Adverse Limb Events (MALD)


Studies investigating:

  • Time in range (TIR)
  • Digital health and TIR
  • 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) 
  • Major adverse cardiovascular events (MACE)


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

  • 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