Epigenetic AgingPhase 2TRIIM-XNCT04375657
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
A Phase 2 study testing TRIIM Treatment in people with Epigenetic Aging and Immunosenescence, run by Intervene Immune, Inc. at 1 site in United States.
Trial summary
The TRIIM-X trial is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. The thymus is a part of the immune system that declines markedly with age, and regenerating it may prevent or reverse key aspects of immunosenescence (immune system aging) and… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Epigenetic Aging, Immunosenescence
- What is being tested?
- TRIIM Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2020to Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female volunteers
- Aged 40 to 80 years, inclusive
- All ethnicities
- Able to participate in 12-month study
- Able to provide informed consent
Who cannot join
- Malignancies or high risk of malignancy, as suggested by familial risk or personal medical history
- Premenopausal women
- Postmenopausal women on HRT
- IGF-1 levels < 90 ng/ml or >300 ng/ml
- Diagnosed or suspected growth hormone resistance
- Known growth hormone deficiency based on stimulation testing
Show all 28Show fewer
- Pre-existing carpal tunnel syndrome
- Significant arthritis/arthralgia/joint swelling
- Bradycardia (<55 bpm), significant hypertension (systolic >160 mmHg, or diastolic >90 mmHg) despite treatment, serious angina, or other serious cardiovascular disease or cardiovascular disease risk factors
- Excessive skin growths (e.g., flat warts) without cryosurgical options
- BMI of 35 or greater
- PSA level above the age-adjusted normal range for reasons other than confirmed prostatitis
- Testosterone levels above the upper limit of normal
- Levels of C-reactive protein (CRP) above the upper limit of normal
- Type 1 or pre-existing Type 2 diabetes
- Uncorrected hypothyroidism
- HIV infection
- Allergy or other sensitivity to study medications
- Other unstable medical conditions
- Use of GH within the last 5 years
- Participation in a clinical research trial within 30 days prior to enrollment
- Use of chronic glucocorticoid therapy
- Unwilling to discontinue androgen supplementation if testosterone levels are above the upper limit of normal
- Ongoing treatment with carbonic anhydrase inhibitors
- Ketogenic diet, calorie-restricted diet, or prolonged fasting, without willingness to discontinue these diets or adhere to an alternative diet during the study
- Alcoholism or drug addiction
- Smoking or unwillingness to quit smoking
- Cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Intervene Immune
Torrance, California, 90502
Robert Brooke, (833) 346-6863, info@interveneimmune.com
Gregory M Fahy, PhD
About this study
The TRIIM-X trial is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. The thymus is a part of the immune system that declines markedly with age, and regenerating it may prevent or reverse key aspects of immunosenescence (immune system aging) and potentially prevent or reverse key parts of the aging process more generally. The study will evaluate biomarkers for epigenetic aging and immunosenescence, as well as evaluate established clinical measures and risk factors for prevention of physical frailty, cancer, cardiovascular disease, diabetes, dementia, and also infectious diseases, including flu and COVID-19.
The study uses multiple agents in combination with personalized doses of recombinant human growth hormone (somatropin), metformin, and DHEA, in a similar manner to how the combination treatment was applied in the earlier TRIIM trial at Stanford, which demonstrated strong statistical significance for the primary efficacy endpoints that will be evaluated in TRIIM-X. Somatropin is approved by the FDA for adult growth hormone deficiency and its use in the study is guided by prior safety data established for that use and also based on safety data available on its prior use in the TRIIM trial and in clinical practice in healthy elderly individuals. There will also be control groups that enable testing of biomarker variability and the contribution of individual medications within the combination treatment.
The objective of the study is to obtain information needed for designing an effective personalized and adaptive treatment regimen for a larger and more diverse study population, and to obtain additional proof of principle for the new use of the medications and biomarkers for preventive medicine. The duration of treatment in the TRIIM-X trial will be 12 months.
- Conditions
- Epigenetic Aging, Immunosenescence
- Being tested
- TRIIM Treatment, Active Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIIM TreatmentCombination product
Personalized combination of somatropin, metformin, and DHEA
Active ControlCombination product
Metformin and DHEA
| Study group | Role | What they receive |
|---|---|---|
| TRIIM Treatment | Experimental | Not described Receives: Combination Product: TRIIM Treatment |
| Active Control | Active comparator | Not described Receives: Combination Product: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Age
DNA methylation based epigenetic age (GrimAge)
Measured: 12 months
Thymus Regeneration
Thymic density based on MRI or CT
Measured: 12 months
Safety and Tolerability
Incidence of treatment-related adverse effects
Measured: 12 months
Secondary outcomes (1)
Immunosenescence
Assessment of naive T cells and immune cell function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start23 Nov 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epigenetic AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- TRIIM-X is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intervene Immune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375657
- Sponsor's protocol ID
- TRIIM-X
- Acronym
- TRIIM-X
- Status last verified
- May 2025
- First submitted
- 3 May 2020
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fahy GM, Brooke RT, Watson JP, Good Z, Vasanawala SS, Maecker H, Leipold MD, Lin DTS, Kobor MS, Horvath S. Reversal of epigenetic aging and immunosenescent trends in humans. Aging Cell. 2019 Dec;18(6):e13028. doi: 10.1111/acel.13028. Epub 2019 Sep 8.
PubMed 31496122
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
- ClinicalTrials.gov ID
- NCT04375657
- Acronym / sponsor ID
- TRIIM-X / TRIIM-X
- Conditions
- Epigenetic Aging, Immunosenescence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Intervene Immune, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The TRIIM-X trial is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. The thymus is a part of the immune system that declines markedly with age, and regenerating it may prevent or reverse key aspects of immunosenescence (immune system aging) and potentially prevent or reverse key parts of the aging process more generally. The study will evaluate biomarkers for epigenetic aging and immunosenescence, as well as evaluate established clinical measures and risk factors for prevention of physical frailty, cancer, cardiovascular disease, diabetes, dementia, and also infectious diseases, including flu and COVID-19.
The study uses multiple agents in combination with personalized doses of recombinant human growth hormone (somatropin), metformin, and DHEA, in a similar manner to how the combination treatment was applied in the earlier TRIIM trial at Stanford, which demonstrated strong statistical significance for the primary efficacy endpoints that will be evaluated in TRIIM-X. Somatropin is approved by the FDA for adult growth hormone deficiency and its use in the study is guided by prior safety data established for that use and also based on safety data available on its prior use in the TRIIM trial and in clinical practice in healthy elderly individuals. There will also be control groups that enable testing of biomarker variability and the contribution of individual medications within the combination treatment.
The objective of the study is to obtain information needed for designing an effective personalized and adaptive treatment regimen for a larger and more diverse study population, and to obtain additional proof of principle for the new use of the medications and biomarkers for preventive medicine. The duration of treatment in the TRIIM-X trial will be 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- TRIIM-X is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration.
| Arm | Type | Receives |
|---|---|---|
| TRIIM Treatment | Experimental | Combination Product: TRIIM Treatment |
| Active Control | Active comparator | Combination Product: Active Control |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female volunteers
- Aged 40 to 80 years, inclusive
- All ethnicities
- Able to participate in 12-month study
- Able to provide informed consent
Key exclusion criteria (28 listed)
- Malignancies or high risk of malignancy, as suggested by familial risk or personal medical history
- Premenopausal women
- Postmenopausal women on HRT
- IGF-1 levels < 90 ng/ml or >300 ng/ml
- Diagnosed or suspected growth hormone resistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIIM TreatmentPersonalized combination of somatropin, metformin, and DHEA | Combination product | TRIIM Treatment |
| Active ControlMetformin and DHEA | Combination product | Active Control |
Primary outcome
Epigenetic Age
Time frame: 12 months
DNA methylation based epigenetic age (GrimAge)
Thymus Regeneration
Time frame: 12 months
Thymic density based on MRI or CT
Safety and Tolerability
Time frame: 12 months
Incidence of treatment-related adverse effects
1 secondary outcome
Immunosenescence
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Background: PubMed 31496122Fahy GM, Brooke RT, Watson JP, Good Z, Vasanawala SS, Maecker H, Leipold MD, Lin DTS, Kobor MS, Horvath S. Reversal of epigenetic aging and immunosenescent trends in humans. Aging Cell. 2019 Dec;18(6):e13028. doi: 10.1111/acel.13028. Epub 2019 Sep 8.
Related trials for Epigenetic Aging
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Not yet recruitingPhase 2
Effects of Switch to Doravirine/Islatravir vs. Continued Antiretroviral Therapy on Biomarkers of Aging Among Virologically Suppressed People With HIV
Epigenetic Aging
Recruiting
Clinical Study on Circadian Genes Dysregulation in Patients With Glucocorticoid Disorders
Cushing Syndrome, Adrenal Insufficiency
Active, not recruiting
Effects of a Multi-Targeted Oral Supplement on Skin, Hair, Sleep, Energy, Cognition, Libido and Epigenetic Biological Clock Age
Skin Ageing, Healthy Ageing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRIIM Treatment in people with Epigenetic Aging and Immunosenescence, run by Intervene Immune, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Age (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04375657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.