Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required) | RFA DK 27 121

Opportunity Information: Apply for RFA DK 27 121

This NIH funding opportunity (RFA-DK-27-121) supports the creation of a consortium of U.S.-based clinical centers that will run clinical trials to identify the safest and most effective ways to use anti-obesity medications (AOMs) in children and adolescents with obesity. The core goal is not simply weight reduction, but developing practical treatment strategies that maximize clinical benefit while minimizing medical, developmental, and psychosocial risks. Projects supported under this NOFO are expected to reflect real-world clinical care, meaning the approaches tested should be feasible to implement in typical pediatric and adolescent healthcare settings rather than requiring highly specialized resources that cannot be sustained outside research environments.

The NOFO emphasizes that pediatric obesity treatment has to be different from adult obesity treatment because children and adolescents are still growing and developing physically and psychologically. As a result, proposed AOM strategies should explicitly support healthy growth and development, adequate nutritional status and intake, and sustained healthy behaviors around eating and physical activity. In addition, the research is expected to pay close attention to mental health and overall well-being, including factors like body image, self-esteem, mood, and quality of life. In other words, the trials should treat weight change as one important outcome, but not the only outcome, and not at the expense of normal development or psychological health.

A major set of priority questions centers on what "optimal" AOM use looks like across development. Applicants are encouraged to test treatment strategies that help determine the best developmental stage to start medication, how quickly weight loss should occur, and what amount of weight loss is appropriate and safe for different ages and pubertal stages. The NOFO also highlights the need to compare or refine medication-related parameters, such as AOM class selection, dosing levels, dosing frequency, and how long medications should be continued. A key underlying concern is avoiding unnecessary long-term or lifelong dependence on AOMs where possible, which means applicants should think carefully about initiation criteria, maintenance plans, tapering or discontinuation strategies, and what supportive interventions might help sustain benefits if medication is reduced or stopped.

Another central emphasis is the role of adjunct lifestyle therapy. The NOFO specifically calls out the content and intensity of lifestyle interventions as a priority area, recognizing that medication alone may not be sufficient and that behavioral supports may be essential for healthy development. Proposed studies may evaluate how different types or "doses" of lifestyle therapy (for example, varying frequency of counseling, structured family-based programs, nutrition education approaches, physical activity supports, sleep and stress components, or other behavioral strategies) interact with medication choice and dosing. The intent is to identify combinations that provide strong outcomes while remaining realistic for clinical practice.

Beyond testing strategies, the NOFO expects investigators to evaluate predictors of response and nonresponse. That includes identifying characteristics that might help clinicians anticipate which youth are likely to benefit from specific AOM strategies and which may have limited benefit or higher risk. Predictors could include clinical factors, behavioral measures, psychosocial factors, or biologic markers, as long as they are collected in a rigorous, standardized way and can inform future personalized or stratified treatment approaches.

Structurally, awards will be made using the NIH cooperative agreement mechanism (U01), which generally means substantial NIH involvement in coordination and oversight beyond what is typical for standard research grants. Funded clinical centers may run independent trials or multicenter trials, but they are expected to function as a coordinated consortium. This includes collaborating on protocol development, agreeing on common measures and data elements, using standardized procedures for data and biospecimen collection, relying on a central laboratory when required, and working together on analyses and publications. The consortium model is meant to accelerate learning across sites, make results more comparable, and enable pooled analyses where appropriate.

This NOFO runs in parallel with a companion opportunity (RFA-DK-27-136), indicating NIH is supporting a broader, linked effort with multiple components. Applicants should be prepared to coordinate with other funded groups and follow consortium-wide requirements for harmonized data collection and shared scientific goals.

In terms of logistics and key facts, the sponsoring agency is the National Institutes of Health, the funding instrument is a cooperative agreement, and the activity category is health research (CFDA 93.847). The application deadline listed is 2026-10-09. NIH anticipates making about 3 awards, with an award ceiling of $1,000,000 (as provided in the source information). Eligible applicants include a wide range of U.S. entities such as state and local governments, tribal governments and organizations, public and private institutions of higher education, nonprofits (including 501(c)(3) and non-501(c)(3)), for-profit organizations (other than small businesses), and small businesses, among others.

Restrictions on foreign involvement are explicit. Non-U.S. entities are not eligible to apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed. That means applicants need to keep the proposed work, performance sites, and formal project components within allowable U.S.-based structures.

Overall, the opportunity is aimed at building an evidence base for pediatric and adolescent AOM use that goes beyond whether a drug can reduce weight, focusing instead on how to use these medications responsibly across development, how to pair them with behavioral supports, how to protect mental and physical health, and how to generate practical guidance clinicians can use to make treatment decisions that are both effective and safe for young people.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2026-06-08.
• Applicants must submit their applications by 2026-10-09. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
• The number of recipients for this funding is limited to 3 candidate(s).
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for RFA DK 27 121

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