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

February 27, 2023 updated by: Intervene Immune, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Torrance, California, United States, 90502
        • Recruiting
        • Intervene Immune
        • Contact:
        • Principal Investigator:
          • Gregory M Fahy, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epigenetic Age
Time Frame: 12 months
DNA methylation based epigenetic age (GrimAge)
12 months
Thymus Regeneration
Time Frame: 12 months
Thymic density based on MRI or CT
12 months
Safety and Tolerability
Time Frame: 12 months
Incidence of treatment-related adverse effects
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunosenescence
Time Frame: 12 months
Assessment of naive T cells and immune cell function
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intervene Immune, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2020

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

May 3, 2020

First Submitted That Met QC Criteria

May 3, 2020

First Posted (Actual)

May 5, 2020

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • TRIIM-X

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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