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

April 16, 2025 updated by: TNF Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;
  10. Previous positive assessment for elevated biomarkers of inflammation (serum IL-6 level> LOQ, TNFR1 level > LOQ, and/or TNF-alpha level > LOQ)

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
  11. Currently under treatment by an anti-diabetic medication, including glucagon-like peptide-1 (GLP-1) drugs such as semaglutide, or any of metformin, jenuvia, or insulin
  12. Unwillingness or inability to comply with study procedures, including smoking cessation
  13. History of epilepsy or seizure propensity, ataxia, abnormal EEG findings, abnormal brain magnetic resonance image, or other co-morbid neurological conditions
  14. Positive TB test
  15. Patients who are pregnant or breastfeeding

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Drug: 1000 mg Isomyosamine
Subjects randomly assigned to receive 1000 mg Isomyosamine daily via four 250 mg capsules
Drug: Isomyosamine 250mg
Isomyosamine 250 mg capsules dosed 4 times daily
Placebo Comparator: Placebo 1000 mg
Subjects randomly assigned to receive 1000 mg placebo daily via four 250 mg capsules
Drug: Placebo 250 mg
Placebo 250 mg capsule 4 times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo
Time Frame: From enrollment to the end of treatment at 90 days
From enrollment to the end of treatment at 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
4-meter walk test
Time Frame: From enrollment to the end of treatment at 90 days
Change in the time taken to walk 4 meters through 90 days dosing.
From enrollment to the end of treatment at 90 days
6-minute walk test
Time Frame: From enrollment to the end of treatment at 90 days
Change in the distance walked in the 6-minute walk test (m) through 90 days dosing.
From enrollment to the end of treatment at 90 days
Grip strength
Time Frame: From enrollment to the end of treatment at 90 days
Change in grip strength score over 90 day dosing.
From enrollment to the end of treatment at 90 days
Effect on serum levels of biochemical markers of TNF activation
Time Frame: From enrollment to the end of treatment at 90 days
From enrollment to the end of treatment at 90 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in the Isomyosamine vs Placebo groups
Time Frame: From enrollment to the end of treatment at 90 days
From enrollment to the end of treatment at 90 days

Collaborators and Investigators

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

Sponsor

TNF Pharmaceuticals, 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.

Helpful Links

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNF001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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