Clinical trial NCT06942182: Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures
Official title: Double Blind Placebo-Controlled Parallel Group Study Of Safety And Efficacy Of Isomyosamine In Treating Sarcopenia After Hip Or Femoral Fracture In Gerontological Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Sarcopenia in Elderly
Frailty
Frailty/Sarcopenia
Frailty in Older Adults
Keywords: sarcopenia
Frailty
Hip Fracture
Older population
Gerontological
Femur fracture
Sarcopenia and Frailty
Lead sponsor: TNF Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo
timeFrame: From enrollment to the end of treatment at 90 days
Secondary outcomes:
measure: 4-meter walk test
timeFrame: From enrollment to the end of treatment at 90 days
measure: 6-minute walk test
timeFrame: From enrollment to the end of treatment at 90 days
measure: Grip strength
timeFrame: From enrollment to the end of treatment at 90 days
measure: Effect on serum levels of biochemical markers of TNF activation
timeFrame: From enrollment to the end of treatment at 90 days
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 in the Isomyosamine vs Placebo groups
timeFrame: From enrollment to the end of treatment at 90 days
Other outcomes:
Locations:
Study officials:
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