Status:
NOT_YET_RECRUITING
Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures
Lead Sponsor:
TNF Pharmaceuticals, Inc.
Conditions:
Sarcopenia in Elderly
Frailty
Eligibility:
All Genders
60-85 years
Phase:
PHASE2
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. Isomyo...
Eligibility Criteria
Inclusion
- Age 60 to 85 years of age
- Non-complex, non-comminuted fracture of the femoral head, femoral neck, or acetabulum due to an accidental (non-neurologic or cardiovascular) fall
- Concomitant medication limited to treatment for chronic conditions
- The ability to give informed consent and comply with study procedures
- Body weight ≥35 kg
- Adequate dietary intake
- Potential subjects' intention to avoid reproductive activity will be confirmed
- And one or more of the following criteria:
- Previous history frailty or sarcopenia diagnosis using standardized tests;
- Positive assessment for frailty or sarcopenia using standardized tests or as per clinician's judgement;
- Previous positive assessment for elevated biomarkers of inflammation (serum IL-6 level\> LOQ, TNFR1 level \> LOQ, and/or TNF-alpha level \> LOQ)
Exclusion
- Receiving immunotherapy for cancer or solid organ transplantation
- Complex or comminuted fracture or fracture of multiple long bones
- Regular treatment for chronic disease including chronic renal failure, chronic heart failure (CHF) cerebrovascular disease including stroke, rheumatoid arthritis, or polymyalgia rheumatica
- Chronic kidney disease (estimated glomerular filtration rate \[eGFR\] \<60 mL/min)
- Newly (\< 2 weeks) diagnosed COVID-19
- Inability or unwillingness to give written informed consent
- 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
- History of adverse reaction or allergy to TNF inhibitor
- 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
- Currently under treatment by an anti-TNFα drug, such as adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, and biosimilars
- 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
- Unwillingness or inability to comply with study procedures, including smoking cessation
- History of epilepsy or seizure propensity, ataxia, abnormal EEG findings, abnormal brain magnetic resonance image, or other co-morbid neurological conditions
- Positive TB test
- Patients who are pregnant or breastfeeding
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06942182
Start Date
May 1 2025
End Date
March 1 2026
Last Update
April 24 2025
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