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    TAME trial (Targeting Aging with Metformin)

    Also known as TAME, Targeting Aging with Metformin

    TAME (Targeting Aging with Metformin) is a planned trial, designed in 2016 for 3,000 people aged 65 to 79, that would measure whether metformin delays a composite of heart disease, cancer, dementia and death.[1][2] Its designers see it as a shift toward targeting aging itself, which the FDA does not recognize as a disease.[3][4]

    Editor reviewedStrict sourcingUpdated Aging and longevity biologyLife sciencesHealth and medicine
    Key facts

    What TAME is

    TAME is a proposed clinical trial of metformin, a drug already used to treat type 2 diabetes.[5] In a 2016 paper its designers said they planned to enrol 3,000 people aged 65 to 79 at about 14 US centres.[1] Rather than study one disease, it would measure time to a new occurrence of a composite outcome: cardiovascular events, cancer, dementia and death.[2] TAME was also designed to assess functional and geriatric endpoints.[6] The American Federation for Aging Research has supported the initiative.[7]

    Why it was designed this way

    TAME is built around the geroscience hypothesis: that slowing aging could delay several chronic diseases at once.[8] Its designers say a positive result would mark a shift from treating each condition separately to targeting aging itself.[3]

    It also has a regulatory dimension. Peer-reviewed papers from 2025 state that the FDA does not recognize aging as a disease and that no regulatory framework exists for approving aging-targeted therapies; TAME instead measures a composite of disease outcomes.[4][2]

    The evidence behind metformin

    TAME’s designers chose metformin partly for its track record. They describe it as a diabetes drug that appears to act on several aging-related mechanisms, some of them unrelated to blood sugar.[9] In their 2016 paper they noted that it had been used with an excellent safety record for more than 60 years, and that in the Diabetes Prevention Program it cut the incidence of type 2 diabetes by 31% compared with placebo over about three years.[10]

    Mouse evidence for metformin is mixed. In the NIA’s interventions-testing-program, metformin’s survival benefit was missed by the standard log-rank test. A 2024 reanalysis with the Gehan test, which is more sensitive to differences in deaths earlier in life, found a benefit in male mice only.[11] That pattern would fit a drug that mainly reduces mortality before midlife, which the reanalysis authors gave as one reason the standard test can miss compounds.[12] Most compounds that extended lifespan in that program worked primarily or only in males, so sex differences are a recurring issue for translating mouse results to mixed-sex human trials.[13] Metformin is already approved for diabetes, and people with type 2 diabetes could not be enrolled in TAME as planned in 2015.[5]

    How TAME compares with other aging trials

    Other aging-drug trials have moved ahead in animals. TRIAD, a randomized trial of rapamycin in 580 pet dogs, uses survival time as its primary outcome.[14] In veterinary medicine the FDA has already accepted effectiveness sections framed around lifespan for Loyal’s dog drugs, including loy-002.[15] In people, the closest completed trials of aging drugs measured narrower outcomes; low-dose rapamycin in healthy adults did not change its primary outcome, visceral fat.[16] For more on how interventions move from mice to people, see how aging interventions are tested.

    Status as of October 2026

    This page could not confirm from primary sources whether TAME has begun enrolment or how much of its funding is secured; reviewers should treat its current status as unknown. As of 2025, peer-reviewed papers stated that the FDA does not recognize aging as a disease.[4] The debate over whether it should is covered in the aging-as-a-disease debate.

    Questions readers ask

    What would TAME measure?

    Time until a new occurrence of any of several outcomes, namely cardiovascular events, cancer, dementia or death, rather than a single disease.[2]

    Why metformin?

    Its designers describe the trial as an initial step toward more effective next-generation drugs. Mouse evidence is mixed. Metformin extended survival in male mice only in a 2024 reanalysis, and its effect had been missed by the standard test.[3][11]

    Is metformin approved for aging?

    No. The FDA does not recognize aging as a disease, and no regulatory framework exists for approving aging-targeted therapies. Metformin is approved to treat diabetes.[4][5]

    Sources

    Each numbered claim is a statement we checked against the sources listed with it. Status shows how well established it is.

    1. [1]

      The TAME (Targeting Aging with Metformin) trial was designed in 2016 to enrol 3,000 people aged 65 to 79 at about 14 US centres. confirmedas of 2016-06-14

    2. [2]

      TAME's primary measure is time to a new occurrence of a composite of cardiovascular events, cancer, dementia and death, rather than any single disease. confirmedas of 2016-06-14

    3. [3]

      TAME's designers present it as an initial step toward more effective next-generation drugs, and say a positive result would mark a shift from treating each medical condition separately to targeting aging itself. confirmedas of 2016-06-14

    4. [4]

      Papers published in 2025 in peer-reviewed journals state that the FDA does not recognize aging as a disease and that no regulatory framework exists for developing or approving therapies that target aging, so such therapies are developed through disease-specific pipelines. confirmedas of 2025-08-04

    5. [5]

      Metformin is a drug approved to treat diabetes; because of that, people with type 2 diabetes could not be enrolled in TAME as originally planned. reportedas of 2015-06-24

    6. [6]

      Besides its composite disease outcome, TAME was designed to assess functional and geriatric endpoints. confirmedas of 2016-06-14

    7. [7]

      The American Federation for Aging Research (AFAR) has supported the TAME initiative. confirmedas of 2016-06-14

    8. [8]

      The geroscience hypothesis proposes that therapies slowing or reversing molecular changes of aging could delay or prevent multiple chronic diseases at once and extend healthy lifespan. confirmedas of 2023-02-09

    9. [9]

      TAME's designers describe metformin as a drug approved to treat diabetes that appears to target a number of aging-related mechanisms, some of them beyond glucose metabolism. confirmedas of 2016-06-14

    10. [10]

      TAME's designers wrote in 2016 that metformin has been used with an excellent safety record for more than 60 years, and that in the Diabetes Prevention Program it cut the incidence of type 2 diabetes by 31% compared with placebo over about three years. confirmedas of 2016-06-14

    11. [11]

      A 2024 reanalysis of ITP data from 2004 to 2022 with the Gehan test, which is more sensitive to mortality differences earlier in life, found that metformin, previously missed by the log-rank test, increased survival in male mice only. confirmedas of 2024-04-17

    12. [12]

      The authors of the 2024 ITP reanalysis note that the standard log-rank test is relatively insensitive to compounds that do not reduce mortality uniformly across the lifespan, and may miss compounds that only reduce mortality before midlife. confirmedas of 2024-04-17

    13. [13]

      Most compounds that extended lifespan in the ITP worked primarily or only in male mice. confirmedas of 2025-07-24

    14. [14]

      TRIAD plans to enrol and randomize 580 dogs, with survival time from randomization as its primary outcome. confirmedas of 2025-02-14

    15. [15]

      In February 2025 the FDA's Center for Veterinary Medicine accepted the reasonable expectation of effectiveness (RXE) section for Loyal's LOY-002, a daily pill intended to extend lifespan in senior dogs. confirmedas of 2025-02-26

    16. [16]

      In PEARL, adverse events were similar across groups and the primary outcome, visceral fat, did not change significantly; some secondary measures improved, such as lean tissue mass and pain in women on 10 mg. confirmedas of 2025-04-04

    Revision history (2)
    1. Page created.
    2. Refresh: added why metformin was chosen, its safety and diabetes-prevention record, more detail on the mouse reanalysis and a comparison with other aging trials. The diabetes-exclusion claim is now marked reported because its only source is a paywalled 2015 news article.

    Created Oct 10, 2026. Last reviewed by an editor on Oct 10, 2026. Next scheduled review: Jan 10, 2027.

    Cite this page

    "TAME trial (Targeting Aging with Metformin)." ContentLora, updated Oct 10, 2026. https://contentlora.com/wiki/tame-trial

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