Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : August 26, 2021
Sponsor:
Information provided by (Responsible Party):
Intervene Immune, Inc.

Tracking Information
First Submitted Date  ICMJE May 3, 2020
First Posted Date  ICMJE May 5, 2020
Last Update Posted Date August 26, 2021
Actual Study Start Date  ICMJE November 23, 2020
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2020)
  • Epigenetic Age [ Time Frame: 12 months ]
    DNA methylation based epigenetic age (GrimAge)
  • Thymus Regeneration [ Time Frame: 12 months ]
    Thymic density based on MRI or CT
  • Safety and Tolerability [ Time Frame: 12 months ]
    Incidence of treatment-related adverse effects
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2020)
Immunosenescence [ Time Frame: 12 months ]
Assessment of naive T cells and immune cell function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
Official Title  ICMJE Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Epigenetic Aging
  • Immunosenescence
Intervention  ICMJE
  • Combination Product: TRIIM Treatment
    Personalized combination of somatropin, metformin, and DHEA
  • Combination Product: Active Control
    Metformin and DHEA
Study Arms  ICMJE
  • Experimental: TRIIM Treatment
    Intervention: Combination Product: TRIIM Treatment
  • Active Comparator: Active Control
    Intervention: Combination Product: Active Control
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2020)
85
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2022
Estimated Primary Completion Date November 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04375657
Other Study ID Numbers  ICMJE TRIIM-X
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intervene Immune, Inc.
Study Sponsor  ICMJE Intervene Immune, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Intervene Immune, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP