Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required)
Closed Posted
- Opportunity number
- RFA-DK-27-121
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Up to $1,000,000
Opportunity facts
- Assistance listings
- Funding instrument
- Cooperative Agreement
- Category
-
- Health
- Eligible applicants
-
- Non-501(c)(3) Nonprofits
- For Profit Organizations
- Higher Education Inst. (Private)
- 501(c)(3) Nonprofits
- County Governments
- Tribal Governments (Federally Recognized)
- Independent School Districts
- State Governments
- Higher Education Inst. (Public)
- Special District Governments
- Tribal Organizations (Not Federally Recognized)
- Other
- City/Township Governments
- Small Businesses
- Public or Indian Housing Auth.
- Points of contact
-
- Voula Osganian voula.osganian@nih.gov
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is soliciting cooperative agreement applications from clinical centers to test anti-obesity medication treatment strategies for youth with obesity, with applications due by October 9, 2026.
Eligible applicants include higher education institutions (public and private), 501(c)(3) and non-501(c)(3) nonprofits, for-profit organizations, state and local governments, tribal governments (federally recognized and not federally recognized), special district governments, city and township governments, independent school districts, small businesses, and public or Indian housing authorities. Non-domestic entities and foreign components of U.S. organizations are ineligible. Only one application per institution is permitted.
The NOFO commits $3 million in direct costs in fiscal year 2027 to fund up to 3 awards, with individual awards capped at $1 million in direct costs annually. The maximum project period is 5 years inclusive of up to 1 year for planning.
Clinical centers will conduct independent or multicenter trials while collaborating on protocol development, common measures and data elements, central laboratory procedures, and shared data analysis. Priority research areas include determining optimal developmental stage for anti-obesity medication initiation, rate and amount of weight loss, medication class and dosing, treatment duration, and content and intensity of adjunct lifestyle therapies. Investigators must evaluate potential predictors of treatment response and nonresponse.
Applicants must use FDA-approved or IND-approved medications and budget for two Steering Committee and two Data Safety Monitoring Board meetings annually. A Consortium Assurance letter demonstrating willingness to participate in consortium activities and use a single IRB is required. Applications must include a Data Management and Sharing Plan and clinical trial registration on ClinicalTrials.gov.
The opportunity falls under CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research) and uses the U01 (Clinical Trial Required) activity code. This NOFO runs in parallel with companion NOFO RFA-DK-27-136.
Synopsis
This Notice of Funding Opportunity (NOFO) invites applications from clinical centers to participate in a consortium to test anti-obesity medication (AOM) treatment strategies for youth with obesity that maximize benefits and minimize risks of AOM use. Such intervention strategies should support the promotion of healthy growth and development; adequate nutritional status/intake, healthy eating and physical activity behaviors; mental health and well-being (e.g., body image, self-esteem, mood, etc.), and quality of life and be feasible to implement in clinical care settings. Priority areas include testing strategies to determine optimal developmental stage for AOM initiation, rate and amount of weight loss, AOM class, dose, frequency, and duration, and content and intensity of adjunct lifestyle therapies that may be imperative to ensure normal psychological and physical development and to potentially avoid lifelong dependence on AOMs. Investigators should also evaluate potential predictors of response/ nonresponse to various treatment strategies under evaluation. The clinical centers may conduct independent or multicenter trials but will collaborate on the development of protocols, use of common measures and data elements, use of a central laboratory and standardized procedures to collect data and biospecimens, and data analyses and manuscripts. This NOFO uses a cooperative agreement mechanism (U01) and runs in parallel with a companion NOFO (RFA-DK-27-136).
Eligibility
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Files
| File | Type | Posted |
|---|---|---|
| PKG00293193.pdf | ||
| RFA-DK-27-121-Full-Announcement.html | HTML file |
On GovTribe
Work this opportunity
- Track it in your pipeline
- Find teaming partners
- Similar grant opportunities
- Ask GovTribe AI about this opportunity