Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial

NCT04375657 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TRIIM-X
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epigenetic Aging; Immunosenescence

Outcome Measures

Primary Outcomes (3)

• Epigenetic Age

  DNA methylation based epigenetic age (GrimAge)

  12 months

• Thymus Regeneration

  Thymic density based on MRI or CT

  12 months

• Safety and Tolerability

  Incidence of treatment-related adverse effects

  12 months

Secondary Outcomes (1)

• Immunosenescence

  12 months

Study Arms (2)

TRIIM Treatment

EXPERIMENTAL

Combination Product: TRIIM Treatment

Active Control

ACTIVE COMPARATOR

Combination Product: Active Control

Interventions

TRIIM Treatment COMBINATION_PRODUCT

Personalized combination of somatropin, metformin, and DHEA

TRIIM Treatment

Active Control COMBINATION_PRODUCT

Metformin and DHEA

Active Control

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Intervene Immune, Inc.: lead

Study Sites (1)

Intervene Immune

Torrance, California, 90502, United States

RECRUITING

Related Publications (1)

• Fahy GM, Brooke RT, Watson JP, Good Z, Vasanawala SS, Maecker H, Leipold MD, Lin DTS, Kobor MS, Horvath S. Reversal of epigenetic aging and immunosenescent trends in humans. Aging Cell. 2019 Dec;18(6):e13028. doi: 10.1111/acel.13028. Epub 2019 Sep 8.

  PMID: 31496122 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: TRIIM-X is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration.

Study Record Dates

• First Submitted: May 3, 2020
• First Posted: May 5, 2020
• Study Start: November 23, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

US (1)