Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Research Coordinating Center (U24 Clinical Trial Not Allowed) | RFA DK 27 136

Opportunity Information: Apply for RFA DK 27 136

This funding opportunity (RFA-DK-27-136) from the National Institutes of Health supports the creation of a single Research Coordinating Center (RCC) that will run and unify a larger consortium focused on anti-obesity medication (AOM) treatment strategies for children and adolescents with obesity. The overall goal is practical, clinically usable evidence on how to use AOMs in youth in ways that maximize health benefits while minimizing risks, especially given the unique needs of growing children and teens. The work is meant to go beyond weight loss alone and explicitly consider healthy growth and development, adequate nutrition and intake, sustainable eating and physical activity behaviors, mental health and well-being (including factors like body image, self-esteem, and mood), and overall quality of life. A strong emphasis is placed on approaches that can realistically be implemented in routine clinical care settings rather than being limited to idealized research environments.

The scientific priorities reflect key unanswered questions in pediatric obesity pharmacotherapy. The consortium is expected to test strategies that help determine when AOMs should be started developmentally (for example, identifying the most appropriate stage of puberty or adolescent development for initiation), what pace and magnitude of weight loss is optimal and safe, and how medication choices and dosing should be tailored. This includes comparing or otherwise evaluating AOM class, dose, frequency, and duration of therapy. The NOFO also highlights the importance of adjunct lifestyle treatment, asking what type and intensity of behavioral and lifestyle support needs to accompany medication to protect physical and psychological development, reinforce healthy behaviors, and potentially reduce the likelihood of long-term or lifelong dependence on medications. In addition, studies are expected to look for predictors of response and nonresponse, meaning characteristics that help identify which youth are most likely to benefit from particular strategies and which may not, supporting a more personalized approach to care.

The consortium structure is central to the announcement. Multiple clinical centers (funded under a companion NOFO, RFA-DK-27-121) will conduct trials that may be single-site or multi-center, but they will not operate independently in isolation. Instead, they are expected to collaborate on shared protocols where appropriate, align on common measures and data elements, use standardized procedures for collecting clinical data and biospecimens, coordinate with a central laboratory, and work together on data analyses and publication plans. In that environment, the RCC functions as the hub that makes the entire effort coherent, comparable, and efficient across sites and studies.

The RCC responsibilities are extensive and cover both operational leadership and technical coordination. The RCC is expected to provide day-to-day management and administrative support for the consortium, organize governance and communications, and keep multi-site activities on track. It must also supply leadership and expertise in statistical design and analysis, helping ensure that trials are appropriately designed to answer the priority questions and that analyses are consistent and rigorous across projects. Another major role is research coordination involving a central laboratory, including harmonizing laboratory workflows and ensuring standardized handling of biospecimens and related data. The RCC must harmonize data collection methods and implement common data elements so that results can be compared or pooled across studies. It will develop and maintain the consortium database, conduct data management and data analyses for consortium studies, and foster collaboration among investigators, including supporting shared manuscripts and cross-site scientific integration.

The award mechanism is a U24 cooperative agreement, which typically means NIH staff will have substantial scientific and programmatic involvement compared with a standard grant mechanism. The title also makes clear that the RCC award itself is "Clinical Trial Not Allowed," meaning the coordinating center is not the entity conducting a clinical trial as the funded activity under this particular award, even though it will support and coordinate trials carried out by the clinical sites funded under the companion announcement. Only one award is expected, and the application deadline listed is October 9, 2026.

Eligibility is broad across U.S.-based organizations, including various levels of government entities, public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses and other for-profits that are not small businesses), tribal governments and tribal organizations, and certain public housing authorities/Indian housing authorities. At the same time, the NOFO is strict about foreign involvement: non-U.S. (non-domestic) organizations cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed. In practical terms, the RCC must be fully domestic, and the coordinated infrastructure and activities must avoid foreign components under NIH definitions.

Taken together, this opportunity is essentially an NIH investment in the core infrastructure, leadership, and analytic backbone needed to generate high-quality, harmonized evidence on pediatric AOM use. The RCC is expected to make multi-center work feasible and scientifically consistent, enabling the consortium to answer real-world questions about when and how to use anti-obesity medications in youth while safeguarding growth, nutrition, mental health, and long-term well-being.

• 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 Research Coordinating Center (U24 Clinical Trial Not Allowed)" 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.)
• The number of recipients for this funding is limited to 1 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.

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