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Thymus Regeneration Therapy for Age-Related Immune Decline (TRIIM-X Trial)
Phase 2
Recruiting
Research Sponsored by Intervene Immune, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 40 to 80 years, inclusive
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
TRIIM-X Trial Summary
This trial is a study to see if a combination of 3 drugs can help regenerate the thymus, which is part of the immune system that declines as we age. The study will also evaluate if this combination can help prevent or reverse aspects of aging and potentially help prevent or reduce the risk of developing age-related diseases.
Who is the study for?
The TRIIM-X trial is for men and women aged 40 to 80, from any ethnicity, who can commit to a year-long study. It's not suitable for smokers, those with growth hormone deficiencies or high cancer risks, people on certain medications like steroids or HRT, anyone with serious heart conditions or uncontrolled diabetes, and premenopausal women.Check my eligibility
What is being tested?
This trial tests a personalized treatment aiming to regenerate the thymus and improve immune function in older adults. It involves recombinant human growth hormone (somatropin), metformin, DHEA doses based on prior trials' safety data. The goal is to refine this regimen for broader use and validate biomarkers related to aging prevention.See study design
What are the potential side effects?
Potential side effects may include reactions typical of growth hormones such as joint pain, swelling due to fluid retention (edema), muscle pain; metformin might cause digestive issues; DHEA could affect mood and energy levels. Individual responses can vary.
TRIIM-X Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 80 years old.
TRIIM-X Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Epigenetic Age
Safety and Tolerability
Thymus Regeneration
Secondary outcome measures
Immunosenescence
TRIIM-X Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TRIIM TreatmentExperimental Treatment1 Intervention
Group II: Active ControlActive Control1 Intervention
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Who is running the clinical trial?
Intervene Immune, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a postmenopausal woman currently on hormone replacement therapy.I am a woman who has not gone through menopause.I have a slow heart rate, high blood pressure, severe chest pain, or other serious heart conditions.I have severe joint pain or swelling.I have or might have growth hormone resistance.You have a problem with drinking too much alcohol or using drugs.I am currently taking medication for carbonic anhydrase inhibitors.I have not used growth hormone in the last 5 years.You were part of another research study within the last month.I have carpal tunnel syndrome.I am on long-term steroid medication.I am between 40 and 80 years old.I am a smoker or not willing to quit smoking.My thyroid is underactive and not treated.I am HIV positive.I do not have any unstable health conditions.You are allergic or sensitive to any of the study medications.I am not willing to stop taking testosterone supplements even if my levels are high.My PSA levels are high, not due to prostatitis.I have been diagnosed with Type 1 or Type 2 diabetes.I have a high risk of cancer due to my family history or past health issues.I am either male or female.People of all ethnic backgrounds are allowed to participate.You are following a specific diet such as the ketogenic or calorie-restricted diet, or prolonged fasting and are not willing to stop or switch to a different diet during the study.I have skin growths that can't be treated with freezing.
Research Study Groups:
This trial has the following groups:- Group 1: TRIIM Treatment
- Group 2: Active Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Intervene Immune
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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