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Can a cancer drug turn back the clock on aging?

NCT ID NCT05835999

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This phase 2 trial tests whether a low dose of everolimus, a drug used in cancer, can safely improve signs of aging in 106 adults aged 55-80 who have insulin resistance or prediabetes. Participants take the drug daily or weekly for 24 weeks, and researchers measure changes in metabolism, heart function, and cognition. A younger group is included for comparison but does not receive the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
everolimus
What this could lead to
If successful, this could point toward a drug that slows some aspects of aging and improves metabolic health in older adults.
What could go wrong
This is a small, early-phase trial. The drug may not work as hoped, and everolimus can cause side effects like mouth sores or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

106 people

The number who actually took part.

Started

Mar 2023

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Adults aged 55-80 years old * Free of overt chronic disease * Willing to provide informed consent * Willing to comply with all study procedures and be available for the duration of the study * Able to use and be contacted by the telephone * Ability to take oral medication * Insulin Resistant defined by HOMA-IR greater than or equal to 1.5 or prediabetic defined as: * impaired fasting glucose (100-125 mg/dL) * HbA1c (5.7-6.4 percent) * glucose 2 hours after a 75 gram oral glucose tolerance test (140-199 mg/dL) * previous diagnosis of prediabetes in the past year * Not planning to change diet or physical activity status * Adequate organ function as indicated by standard laboratory tests: hematology (complete blood count), clinical chemistry and urinalysis * Females of childbearing potential must have a negative urine pregnancy test before DEXA and before the oral glucose tolerance test (OGTT). A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Women of childbearing potential in sexual relationships with men must use an acceptable method of contraception from 30 days prior to enrollment until 4 weeks after completing study visits. Males must agree to avoid impregnation of women during and for four weeks after completing study visits through use of an acceptable method of contraception. * Note: Includes, but is not limited to, barrier with additional spermicidal foam or jelly, intrauterine device, hormonal contraception (started at least 30 days prior to study enrollment), intercourse with men who underwent vasectomy. Inclusion Criteria: Younger Adults aged 18-35 (No intervention) * Free overt chronic disease Exclusion Criteria: * Pregnancy or breastfeeding * Heart disease * Cerebrovascular disease * Cancer or less than 5 years in remission * Chronic respiratory disease * Chronic liver disease * Diabetes * Alzheimer's * Chronic kidney disease * For those undergoing muscle biopsy: problems with bleeding, on medication that prolongs bleeding time * Taking azathioprine (Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), dexamethasone (Decadron, Dexpak), methotrexate (Rheumatrex, Trexall), prednisolone (Orapred, Pediapred, Prelone), prednisone (Sterapred), sirolimus (Rapamune), and tacrolimus (Prograf) or other medications proposed to lower the immune system. Daily use of high potency topical corticosteroids used on greater than or equal to 10% of body surface area will not be eligible. Nasal sprays or inhaled corticosteroids will be reviewed on a case-by-case basis. * Taking strong or moderate CYP3A4 and/or P-glycoprotein (PgP) inhibitors * Taking strong CYP3A4 activators * Taking daily NSAIDs with the exception of baby asprin (81 mg) * Subjects who are not willing to restrict the use of grapefruit, grapefruit juice, and other foods that are known to inhibit cytochrome P450 and PgP activity and may increase everolimus exposures and should be avoided during treatment * Subjects who are not willing to restrict the use of St. John's Wort (Hypericum perforatum) because it may decrease everolimus exposure unpredictably * Subjects who are not willing to avoid blood donations 8 weeks prior to the first visit and 8 weeks after the last visit * For those undergoing MRI, contraindications with MRI which could include metal on your body * Low white-blood cell count (\<3,000 cell/µL) * History of stomatitis or ulcers in the mouth * Those on glucose lowering drugs * Participating in intensive exercise training program (high to moderate intensity exercise greater than 150 minutes per week) or planning to start new exercise program during study period * Tobacco use * Allergies to lidocaine or everolimus * Subjects currently enrolled in other clinical trials. Subjects may be eligible after a washout period that will be reviewed on a case by case basis. * Individuals with limited English proficiency * Subjects who are planning to have elective surgery 12 weeks prior to or during the intervention

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Conditions

The condition(s) this trial relates to.

Insulin Resistance prediabetes syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53705, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.