Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required)

The National Institutes of Health, through the National Institute of Diabetes and Digestive and Kidney Diseases, is offering a funding opportunity titled Optimal Treatment Strategies for use of Anti-Obesity Medications in Children and Adolescents Clinical Centers under a cooperative agreement mechanism. This program is designed to support clinical centers participating in a consortium focused on improving treatment approaches for pediatric obesity using anti-obesity medications. The initiative aligns with the broader mission of the NIH to advance biomedical research and improve prevention, diagnosis, and treatment of chronic diseases, particularly those related to metabolic and endocrine health. The primary purpose of this funding opportunity is to generate rigorous clinical evidence on how anti-obesity medications can be used safely and effectively in children and adolescents. The program emphasizes optimizing treatment strategies that balance weight loss outcomes with healthy growth, psychological well-being, and long-term safety. Funded clinical centers will contribute to collaborative studies examining medication timing, dosage, duration, and integration with behavioral and lifestyle interventions. Research must also address variability in patient response and identify predictors of treatment success or failure. Funding is provided through cooperative agreements, meaning NIH will have substantial involvement in project activities. The program anticipates up to three awards with a total of approximately three million dollars in direct costs. Individual project budgets may request up to one million dollars per year for a maximum project period of five years, including a potential planning phase. Funds must be used to support clinical trials involving FDA-approved or appropriately authorized medications, as well as associated research infrastructure, data collection, and collaboration activities. Cost sharing is not required for this opportunity. Eligibility for this program is broad and includes higher education institutions, nonprofit organizations, for-profit entities, and government agencies at various levels within the United States. However, foreign organizations and non-domestic components are not eligible to apply. Applicants must demonstrate prior experience conducting clinical trials in pediatric obesity and assemble multidisciplinary teams with expertise in relevant scientific and clinical areas. Only one application per institution is permitted. The application process requires submission through Grants.gov using NIH-approved systems such as ASSIST or institutional system-to-system solutions. Applicants must comply with all NIH application guidelines and include required components such as a data management and sharing plan, human subjects documentation, and consortium participation assurances. Applications undergo a rigorous peer review process evaluating scientific merit, feasibility, innovation, and investigator qualifications, followed by advisory council review and funding decisions based on merit, relevance, and available funds. Key dates for this opportunity include an opening date of September 9, 2026, and a submission deadline of October 9, 2026. Applications must be submitted by 5:00 PM local time. Review is expected in March 2027, with advisory council review in May 2027 and earliest project start dates in July 2027. The funding opportunity is not explicitly recurring, and late applications will not be accepted. Applicants are encouraged to submit early to allow time for corrections and ensure compliance with submission requirements.

Emphasize rigorous study design, feasibility, and multidisciplinary expertise; demonstrate prior clinical trial experience; align closely with NIH priorities; ensure compliance with all application instructions