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 Type : Interventional (Clinical Trial)
Estimated Enrollment : 85 participants
Intervention Model: Parallel Assignment
Intervention Model Description: TRIIM-X is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2022
United States, California
Intervene Immune Recruiting
Torrance, California, United States, 90502
Contact: Robert Brooke 833-346-6863 firstname.lastname@example.org
Principal Investigator: Gregory M Fahy, PhD
Sponsors and Collaborators
Intervene Immune, Inc.