Opportunity Information: Apply for PAR 23 279
The National Institutes of Health (NIH) is offering an R01 grant opportunity titled "Mechanisms that Impact Cancer Risk with Use of Incretin Mimetics (R01 Clinical Trial Optional)" (Funding Opportunity Number PAR-23-279; CFDA 93.393). This discretionary grant focuses on understanding how incretin mimetic therapies, including GLP-1 agonists or antagonists, GIP-1 agonists or antagonists, and dual GLP-1/GIP-1 agents, may influence cancer risk. The main point is not to re-test short-term outcomes that are already commonly studied (like weight loss, glycemic control, or near-term metabolic improvements), but to dig into the biological mechanisms that could explain why these drugs might change cancer risk in different directions depending on the cancer type.
The funding announcement has two core goals. First, it aims to stimulate both preclinical and patient-based research that directly examines the mechanism(s) through which incretin mimetics affect cancer risk. That includes laboratory work that can establish causality and identify pathways, as well as human-focused studies that can connect drug exposure to meaningful biological changes in tissues, immune function, endocrine signaling, inflammation, or other cancer-relevant processes. Second, NIH is explicitly trying to pull in investigators who already understand the complex and dynamic physiological shifts caused by incretin mimetics and encourage them to apply that expertise to cancer biology questions, rather than staying limited to the traditional diabetes and obesity endpoints.
A key rationale for the opportunity is the emerging, mixed picture in the existing evidence base. Available data suggest that incretin mimetics could potentially increase the risk of some cancers while decreasing the risk of other cancers, particularly within the group of cancers associated with obesity. This creates an urgent need to move beyond correlation and establish plausible mechanistic explanations. In practice, NIH is signaling strong interest in research that can disentangle direct drug effects from indirect effects mediated by weight loss, insulin and IGF signaling changes, altered nutrient handling, shifts in bile acids, chronic inflammation changes, microbiome effects, or immune modulation. The emphasis on "mechanisms" means projects should be designed to explain the "how" and "why" behind cancer risk changes, rather than simply reporting whether a risk signal exists.
The mechanism emphasis also implies that strong applications will likely integrate more than one line of evidence, such as pairing animal or cellular models with patient biospecimens, using molecular profiling to map pathway changes, or leveraging clinical datasets in ways that are tied to biological hypotheses. Because the announcement is labeled "Clinical Trial Optional," applicants are not required to run a clinical trial, but they may include one if it is justified by the mechanistic aims. That flexibility supports a wide range of study designs, from bench science through translational studies and carefully targeted clinical investigations.
Eligibility is broad and includes many types of U.S. organizations, such as state, county, city, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; and other tribal organizations. It also includes public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and an "other" category that typically captures additional entities allowed under NIH policy. The announcement also highlights additional eligible applicants that NIH often encourages to apply, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. (foreign) organizations.
The opportunity was created on August 23, 2023, and lists an original closing date of January 7, 2027. While the award ceiling and expected number of awards are not specified in the provided source data, the mechanism being an R01 generally indicates support for substantial, multi-year research projects with a clear hypothesis-driven structure, rigorous methods, and a strong plan for producing actionable mechanistic insight. Overall, NIH is using this announcement to accelerate high-quality science that clarifies whether, when, and through what pathways incretin mimetics may alter cancer risk, with the longer-term goal of improving patient safety, guiding clinical decision-making, and informing future drug development and risk mitigation strategies.Apply for PAR 23 279
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Mechanisms that Impact Cancer Risk with Use of Incretin Mimetics (R01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.393.
- This funding opportunity was created on 2023-08-23.
- Applicants must submit their applications by 2027-01-07.
- 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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Frequently Asked Questions (FAQs)
What is the title of this NIH funding opportunity?
The funding opportunity is titled "Mechanisms that Impact Cancer Risk with Use of Incretin Mimetics (R01 Clinical Trial Optional)."
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is PAR-23-279.
What is the CFDA number listed for this opportunity?
The CFDA number provided is 93.393.
What type of grant mechanism is being offered?
This opportunity uses the NIH R01 mechanism, which is generally intended for substantial, hypothesis-driven research projects.
What is the main scientific focus of the opportunity?
The main focus is understanding the biological mechanisms through which incretin mimetic therapies may influence cancer risk, including the possibility that risk could increase for some cancers and decrease for others.
Which drug classes are included under "incretin mimetics" in this announcement?
The opportunity explicitly includes GLP-1 agonists or antagonists, GIP-1 agonists or antagonists, and dual GLP-1/GIP-1 agents.
Is the goal to evaluate common short-term outcomes like weight loss or glycemic control?
No. The announcement emphasizes that the primary point is not to re-test short-term outcomes that are already commonly studied (such as weight loss, glycemic control, or near-term metabolic improvements). Instead, the emphasis is on explaining how and why cancer risk might change.
What are the two core goals NIH highlights for this opportunity?
First, to stimulate preclinical and patient-based research that directly examines the mechanisms through which incretin mimetics affect cancer risk. Second, to bring in investigators who understand the complex physiological shifts caused by these therapies and apply that expertise to cancer biology questions.
Why is NIH emphasizing "mechanisms" rather than correlation?
NIH cites an emerging, mixed evidence base suggesting incretin mimetics could potentially increase the risk of some cancers while decreasing the risk of others, particularly among cancers associated with obesity. This creates a need to move beyond correlation and establish plausible mechanistic explanations.
What kinds of mechanistic pathways is NIH interested in disentangling?
NIH signals interest in research that can distinguish direct drug effects from indirect effects mediated by factors such as weight loss, changes in insulin and IGF signaling, altered nutrient handling, shifts in bile acids, changes in chronic inflammation, microbiome effects, or immune modulation.
What types of research approaches does NIH want to stimulate?
The announcement encourages both preclinical and patient-based research. This can include laboratory work that establishes causality and identifies pathways, as well as human-focused studies that connect drug exposure to meaningful biological changes relevant to cancer processes.
Does the opportunity encourage combining multiple lines of evidence?
Yes. The mechanism emphasis implies that strong applications will likely integrate more than one line of evidence, such as pairing animal or cellular models with patient biospecimens, using molecular profiling to map pathway changes, or leveraging clinical datasets in ways tied to biological hypotheses.
Are clinical trials required under this opportunity?
No. Because the opportunity is labeled "Clinical Trial Optional," applicants are not required to run a clinical trial.
Can a clinical trial be included in an application?
Yes. A clinical trial may be included if it is justified by the mechanistic aims of the proposed research.
What is the intended scope of projects under an R01 in this context?
While the award ceiling and expected number of awards are not specified in the provided information, the R01 mechanism generally supports substantial, multi-year projects with clear hypotheses, rigorous methods, and a strong plan for producing actionable mechanistic insight.
What is the overall long-term purpose of NIH supporting this research?
The stated aim is to accelerate high-quality science that clarifies whether, when, and through what pathways incretin mimetics may alter cancer risk, with longer-term goals that include improving patient safety, guiding clinical decision-making, and informing future drug development and risk mitigation strategies.
Who is eligible to apply (in general terms)?
Eligibility is broad and includes many types of U.S. organizations, including various government entities, educational institutions, tribal governments and organizations, housing authorities, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses, as well as other eligible entities allowed under NIH policy.
Are state, county, city, and special district governments eligible?
Yes, these types of government organizations are listed as eligible.
Are institutions of higher education eligible?
Yes. Both public/state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other tribal organizations are listed as eligible.
Are public housing authorities or Indian housing authorities eligible?
Yes, public housing authorities/Indian housing authorities are listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits with or without 501(c)(3) status are listed as eligible.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed, and small businesses are also listed separately as eligible.
Are non-U.S. (foreign) organizations eligible to apply?
Yes. The announcement highlights non-U.S. (foreign) organizations among the additional eligible applicants it often encourages to apply.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are highlighted among additional eligible applicants.
Are certain institution types specifically encouraged to apply?
Yes. The announcement highlights that NIH often encourages applications from Alaska Native and Native Hawaiian Serving Institutions, AANAPISISs, Hispanic-serving Institutions, HBCUs, TCCUs, and faith-based or community-based organizations, among others.
When was this opportunity created?
The opportunity was created on August 23, 2023.
What is the original closing date listed?
The original closing date listed is January 7, 2027.
Does the provided information specify an award ceiling or the expected number of awards?
No. The provided source data states that the award ceiling and expected number of awards are not specified.
What kinds of biological changes in humans are considered relevant to the mechanistic aims?
The announcement points to connecting drug exposure to meaningful biological changes in areas such as tissues, immune function, endocrine signaling, inflammation, and other cancer-relevant processes.
How does NIH describe the evidence base that motivates this opportunity?
NIH describes an emerging and mixed picture: available data suggest incretin mimetics could potentially increase risk for some cancers while decreasing risk for others, especially within obesity-associated cancers, driving the need for mechanistic clarity.
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