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
- Optimization of diagnosis
- Pathophysiology of PH
- Improving diagnostics and Monitoring Tools
- Advancing the understanding of Primary Hyperoxaluria (PH) management
- Optimizing outcomes and clinical benefit
- Protocols not in conflict or redundant with NNI research/scientific commitment in the thereaputic area
Areas of interest
- Norditropin authorized indications [GHD/AGHD/SGA/Turner syndrome/PWS/ NS/ISS]
- Early initiation of treatment, treatment optimisation
- Prediction of growth during GH therapy
- Epidemiology of approved conditions
- HEOR/PRO/QoL studies
- Devices
- Adherence/persistence in GHT
- Genetics of growth and growth disorders, growth charts
- Short stature in rare or undefined genetic disorders or syndromes
- Synergistic use (GH + other products)
- MASH in AGHD/GHD
- New disease areas: Acromegaly, CAH, Achondroplasia, XLH, HypoPTH (natural history, chart reviews)
- Other Protocols not in conflict or redundant with NNI research/scientific commitment in the thereaputic area
Areas not in scope
- Studies that overlap with completed, ongoing or planned research
- Burns anti-ageing, and sports performance enhancement
- Request for placebo only
Areas of interest
- Somapacitan authorized indications –AGHD
- Adherence/Persistence/treatment initiation
- Traumatic Brain Injury
- Metabolic outcomes (e.g., lipid metabolism)
- Impact on Liver function / hepatic fat (e.g., AGHD with MAFLD/MASH comorbidity)
- Switching from daily GH; switching between Long-acting growth hormone brands
- Combination treatment somapacitan & GLP-1
- Titration and Insulin-like growth factor -1 (IGF-I) excursions
- Health Economic outcomes (e.g., work productivity), PRO/QoL
- Transition GHD to adulthood
- Other protocols not in conflict or redundant with NNI research/scientific commitment in the therapeutic area
Areas not in scope
- Studies that overlap with completed, ongoing or planned research
- Abuse (i.e., anti-ageing, doping)
- Request for placebo only
Areas of interest
- Somapacitan authorised indications – GHD where approved
- Somapacitan use in children with GHD below 2.5 years
- Use in paediatric Prader-Willi patients
- Adherence/persistence/treatment initiation
- Prediction of growth during somapacitan therapy
- Metabolic outcomes (e.g., lipid metabolism)
- Impact on body composition
- Switching from daily GH
- Switching from weekly GH
- Impact on energy levels, QoL
- Transition GHD to adulthood quality of life
- Endocrine sequalae in cancer survivor and long-acting growth hormone use
- Other protocols not in conflict or redundant with NNI research/scientific commitment in the therapeutic area
Areas not in scope
- Studies that overlap with completed, ongoing or planned research
- General off-label use in non-short stature patients
- Use in paediatric non-replacement indications currently under clinical investigation in the REAL program
- Abuse (i.e., anti-ageing, doping)
- Request for placebo only
Unmet needs in Sickle Cell Disease and/or Thalassemia including:
- Humanistic
- Clinical
- Social Burden
Sickle Cell Disease and/or Thalassemia related to:
- Improving disparity-related health outcomes
- Improving access to equitable care
- Quantifying barriers to care
- Care models and outcomes
Long-term outcomes associated with:
- Care models and/or effective/ineffective continuity of care including pediatric to adult transition
Association between treatment biomarkers and:
- Humanistic outcomes
- Clinical outcomes
- Other outcomes
Studies that overlap with competed, ongoing or planned research
- Protocol
- Detailed line-item budget
- Principal Investigator CV
- Active medical license (e.g., if requesting study drug)
- Conflict of Interest form
October 1st 2024
December 2024
March 1st 2025
May 2025