Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial

Recruiting now · Phase 2

Conditions studied: Epigenetic Aging, Immunosenescence

In brief

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.

Key facts

Study ID: NCT04375657
Run by: Intervene Immune, Inc.
People needed: 85
Starts: 2020-11-23
Expected to finish: 2025-12-01
Last updated by the study team: 2025-05-07

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female volunteers
Aged 40 to 80 years, inclusive
All ethnicities
Able to participate in 12-month study
Able to provide informed consent

You may not qualify if…

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

Where it is running

Intervene Immune — Torrance, California, United States (enrolling)

Full record on ClinicalTrials.gov

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