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NCT04375657 · ClinicalTrials.gov registry record · Phase 2
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
A Phase 2 study of Epigenetic Aging and Immunosenescence, sponsored by Intervene Immune.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 85
- Enrollment target
- 1
- Study location
NCT04375657: Recruiting Phase 2 study of Epigenetic Aging and Immunosenescence, sponsored by Intervene Immune.
NCT04375657 is a Phase 2 study of Epigenetic Aging and Immunosenescence that is actively recruiting participants, run by Intervene Immune. The registered enrollment target is 85 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04375657, a Phase 2 study of Epigenetic Aging and Immunosenescence, is actively recruiting participants, sponsored by Intervene Immune.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 85 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
DNA methylation based epigenetic age (GrimAge)
Conditions Studied
Interventions
- COMBINATION_PRODUCT TRIIM Treatment
- COMBINATION_PRODUCT Active Control
Study Locations (1)
California
- Intervene Immune - Torrance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT04375657 shows while recruiting
NCT04375657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (36% lower).
The record links to 2 conditions, with Epigenetic Aging appearing as the primary indexed condition, and to 2 interventions - of which TRIIM Treatment is the first listed.
NCT04375657 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04375657 about?
NCT04375657 is a clinical study titled "Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial". 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...
What is the current status of trial NCT04375657?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 85 participants. The study started on 2020-11-23. Estimated completion is 2025-12.
What conditions does trial NCT04375657 study?
This clinical trial studies the following conditions: Epigenetic Aging, Immunosenescence.
What interventions are being tested in trial NCT04375657?
The interventions under investigation include: TRIIM Treatment (COMBINATION_PRODUCT), Active Control (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04375657?
This trial is sponsored by Intervene Immune, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04375657 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04375657's enrollment target sits among peer trials
85 820th of 2000 higher than 1,180 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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