Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial

Part of paid clinical trials in Torrance, California.

Sponsor
Intervene Immune, Inc.
Study ID
NCT04375657
Phase
PHASE2
Status
Recruiting
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Conditions

  • Epigenetic Aging
  • Immunosenescence

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • TRIIM Treatment — COMBINATION_PRODUCT
    Personalized combination of somatropin, metformin, and DHEA
  • Active Control — COMBINATION_PRODUCT
    Metformin and DHEA

Study Details

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 Dates

Start date
Nov 23, 2020
Status verified
May 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
85 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TRIIM Treatment
  • Active Comparator: Active Control

Primary Outcome Measure

Epigenetic Age [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Intervene ImmuneTorranceCalifornia90502
Robert Brooke
[email protected]
(833) 346-6863
Gregory M Fahy, PhD (PRINCIPAL_INVESTIGATOR)

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Intervene Immune· Torrance, CA

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