Phase 2Recruiting
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial (TRIIM-X)
- Sponsor
- Intervene Immune, Inc. (Industry)
- Enrolment
- 85 planned
- Conditions
- Epigenetic Aging; Immunosenescence
- Interventions
- TRIIM Treatment; Active Control
- Ages
- adults, older adults
- Registry
- NCT04375657
From the registry
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…
Primary outcomes
- Epigenetic Age
- Thymus Regeneration
- Safety and Tolerability