NCT04375657 · Intervene Immune, Inc.
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
(TRIIM-X)
What this study is about
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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
TRIIM Treatment
Personalized combination of somatropin, metformin, and DHEA
COMBINATION_PRODUCT
Active Control
Metformin and DHEA
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female volunteers
- Aged 40 to 80 years, inclusive
- All ethnicities
- Able to participate in 12-month study
- Able to provide informed consent
Exclusion criteria
- 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
- 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
Where
- Torrance, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2025 · Source of record for eligibility and locations