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Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures | Clinical Trials | Clareo Health

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Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures

Double Blind Placebo-Controlled Parallel Group Study Of Safety And Efficacy Of Isomyosamine In Treating Sarcopenia After Hip Or Femoral Fracture In Gerontological Population

NCT06942182•TNF Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This Phase II clinical study investigates the safety and effectiveness of a new drug, Isomyosamine, in patients with sarcopenia or frailty, conditions associated with aging and muscle weakness. Isomyosamine is a promising oral medication that reduces inflammation by targeting cytokines like TNF-α and IL-6, which are linked to these conditions. Previous studies have shown it is well-tolerated and may help improve muscle strength, mobility, and healing after hip fractures. This trial aims to determine its potential benefits in reducing inflammation and improving recovery in elderly patients.

Eligibility

Age

60 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 60 to 85 years of age
•2. Non-complex, non-comminuted fracture of the femoral head, femoral neck, or acetabulum due to an accidental (non-neurologic or cardiovascular) fall
•3. Concomitant medication limited to treatment for chronic conditions
•4. The ability to give informed consent and comply with study procedures
•5. Body weight ≥35 kg
•6. Adequate dietary intake
•7. Potential subjects' intention to avoid reproductive activity will be confirmed
•And one or more of the following criteria:
•8. Previous history frailty or sarcopenia diagnosis using standardized tests;
•9. Positive assessment for frailty or sarcopenia using standardized tests or as per clinician's judgement;
+1 more criteria

Exclusion Criteria

•1. Receiving immunotherapy for cancer or solid organ transplantation
•2. Complex or comminuted fracture or fracture of multiple long bones
•3. Regular treatment for chronic disease including chronic renal failure, chronic heart failure (CHF) cerebrovascular disease including stroke, rheumatoid arthritis, or polymyalgia rheumatica
•4. Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] \<60 mL/min)
•5. Newly (\< 2 weeks) diagnosed COVID-19
•6. Inability or unwillingness to give written informed consent
•7. History of upper/lower respiratory tract infection, requiring systemic steroids, antibiotics, and or emergency room (ER) visit or urgent care within 6 weeks of screening visit
•8. History of adverse reaction or allergy to TNF inhibitor
•9. History of neurological, hepatic, renal, diabetic mellitus, thyroid disorder, psychiatric, addiction or other medical conditions that may interfere with the interpretation of data or the patient's participation in the study or may increase safety concerns per investigator discretion
•10. Currently under treatment by an anti-TNFα drug, such as adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, and biosimilars
+5 more criteria

Key Dates

Start Date

May 1, 2025

Primary Completion Date

March 1, 2026

Completion Date

March 1, 2026

Last Updated

April 24, 2025

Enrollment

ESTIMATED participants

Conditions

Sarcopenia in ElderlyFrailtyFrailty/SarcopeniaFrailty in Older Adults

Interventions

Isomyosamine 250mg

DRUG

Placebo 250 mg

DRUG

Contacts

Dan Mazzucco

CONTACT

dmazzucco@3-e-a.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures

Inclusion Criteria

Exclusion Criteria

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