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Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial (TRIIM-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04375657
Recruitment Status : Recruiting
First Posted : May 5, 2020
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Intervene Immune, Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Epigenetic Aging Immunosenescence Combination Product: TRIIM Treatment Combination Product: Active Control Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85 participants
Allocation: Randomized
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
Actual Study Start Date : November 23, 2020
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: TRIIM Treatment Combination Product: TRIIM Treatment
Personalized combination of somatropin, metformin, and DHEA
Active Comparator: Active Control Combination Product: Active Control
Metformin and DHEA


Outcome Measures
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Primary Outcome Measures :
  1. Epigenetic Age [ Time Frame: 12 months ]
    DNA methylation based epigenetic age (GrimAge)

  2. Thymus Regeneration [ Time Frame: 12 months ]
    Thymic density based on MRI or CT

  3. Safety and Tolerability [ Time Frame: 12 months ]
    Incidence of treatment-related adverse effects


Secondary Outcome Measures :
  1. Immunosenescence [ Time Frame: 12 months ]
    Assessment of naive T cells and immune cell function


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female volunteers
  • Aged 40 to 80 years, inclusive
  • All ethnicities
  • Able to participate in 12-month study
  • Able to provide informed consent

Exclusion Criteria:

  • 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
  • Uncorrected hypothyroidism
  • HIV infection
  • Allergy or other sensitivity to study medications
  • Other unstable medical conditions
  • Use of GH within the last 5 years
  • Participation in a clinical research trial within 30 days prior to enrollment
  • Use of chronic glucocorticoid therapy
  • Unwilling to discontinue androgen supplementation if testosterone levels are above the upper limit of normal
  • Ongoing treatment with carbonic anhydrase inhibitors
  • Ketogenic diet, calorie-restricted diet, or prolonged fasting, without willingness to discontinue these diets or adhere to an alternative diet during the study
  • Alcoholism or drug addiction
  • Smoking or unwillingness to quit smoking
  • Cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04375657


Locations
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United States, California
Intervene Immune Recruiting
Torrance, California, United States, 90502
Contact: Robert Brooke    833-346-6863    info@interveneimmune.com   
Principal Investigator: Gregory M Fahy, PhD         
Sponsors and Collaborators
Intervene Immune, Inc.
More Information
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Publications:

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Responsible Party: Intervene Immune, Inc.
ClinicalTrials.gov Identifier: NCT04375657    
Other Study ID Numbers: TRIIM-X
First Posted: May 5, 2020    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No