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
Obesity-related complications:
- Obstructive sleep apnea
- Women’s health
- Polycystic ovarian syndrome (not related to infertility)
- Menopause
- Skin disorders
- Inflammatory disorders
- Atherosclerosis
Surgery:
- Pre-bariatric surgery
- Time to eligibility for surgery
- Combination with minimally-invasive devices
Mechanistic/Mode of action studies:
- Hedonic eating
- Neuroimaging
- Energy expenditure
- Metabolic adaptation
- Weight maintenance
- Body composition
- Changes in epicardial fat
- Atherosclerosis
Rare/genetic obesity:
- Acquired hypothalamic obesity – craniopharyngiomia
- Syndromic obesity – Prader-Willi, Bardet-Biedl, Alstrom
- Genetic obesity -- MC4R, POMC, Leptin
Drug-induced obesity:
- Antipsychotics
- Anti-retroviral therapy
- Immunosuppressants
Adolescent obesity:
- Family interventions
- Digital solutions
Other:
- Binge eating disorders
- 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
- Glycemic endpoint as the primary outcome
- Dose >2.4 mg/week
- Pregnancy & infertility
- In-vitro and animal studies
- Request for placebo only
- Request for Liraglutide 3.0mg
- Open-label, non-randomized studies, unless compelling reason otherwise (e.g., rare genetic forms of obesity)
Obesity subpopulations:
- Adolescents
- Older aged individuals
- 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 related outcomes relative to:
- Screening and diagnosis
- Care pathways/guidelines
Obesity in relation to:
- Primary prevention of disease with intentional weight loss
- Obesity pathophysiology (e.g., metabolic adaptation) and body composition
- Biomarkers of systemic inflammation (e.g., hsCRP)
Other:
- Protocols not in conflict or redundant with NN research/scientific commitment in the thereaputic area
- Studies that overlap with completed, 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
March 1st 2024
May 2024
October 1st 2024
December 2024