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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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