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.
Areas of interest
Type 2 diabetes (T2D) indication:
- Glycemic endpoints
Cardiovascular effects:
- Mode of action studies
- Studies focused on patients
with:
- Atherosclerotic cardiovascular disease (ASCVD)
- Stroke
- Peripheral artery disease (PAD)
Chronic kidney disease:
- Mode of action studies
- Studies investigating renal benefits
Other:
- Protocols not in conflict or redundant with NN research/scientific commitment in the therapeutic area
Areas not in scope
- Studies that overlap with completed, ongoing or planned research
- Weight as primary endpoint
- Dose >2.0 mg/week
- Pediatric population <18 years
- Pregnancy & infertility
- In-vitro and animal studies
- Request for placebo only
- Request for Liraglutide 1.8 mg
- Open-label, non-randomized studies, unless strong rationale for design
Areas of Interest
Studies investigating oral semaglutide as an early treatment option for patients with Type 2 diabetes (T2D):
- Oral semaglutide as an early treatment option
T2D complications and comorbidities:
- Clinical benefit on microvascular complications
Mode of action:
- Atherosclerotic cardiovascular disease (ASCVD)
- Stroke
- Peripheral artery disease (PAD)
- Chronic kidney disease (CKD)
Treatment preference and adherence:
- Patient preference for oral medications
- Ease of use and adherence to dosing conditions
- Patient and physician related outcomes
Other:
- Benefits of weight loss in T2D
- Time in range and Continuous glucose monitoring
- Management of gastrointestinal side effects in a clinical setting
- Protocols not in conflict or redundant with NN research/scientific commitment in the therapeutic area
Areas not in scope
- Studies that overlap with completed, ongoing or planned research
- Weight as the primary endpoint
- Dose >14 mg/day
- Type 1 diabetes
- Request for placebo only
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
March 1st 2024
May 2024
October 1st 2024
December 2024