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

NCT06942182 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: TNF001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcopenia in Elderly; Frailty; Frailty/Sarcopenia; Frailty in Older Adults

Keywords

sarcopenia; Frailty; Hip Fracture; Older population; Gerontological; Femur fracture; Sarcopenia and Frailty

Outcome Measures

Primary Outcomes (1)

• Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo

  From enrollment to the end of treatment at 90 days

Secondary Outcomes (5)

• 4-meter walk test

  From enrollment to the end of treatment at 90 days

• 6-minute walk test

  From enrollment to the end of treatment at 90 days

• Grip strength

  From enrollment to the end of treatment at 90 days

• Effect on serum levels of biochemical markers of TNF activation

  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

  From enrollment to the end of treatment at 90 days

Study Arms (2)

Study Drug: 1000 mg Isomyosamine

EXPERIMENTAL

Subjects randomly assigned to receive 1000 mg Isomyosamine daily via four 250 mg capsules

Drug: Isomyosamine 250mg

Placebo 1000 mg

PLACEBO COMPARATOR

Subjects randomly assigned to receive 1000 mg placebo daily via four 250 mg capsules

Drug: Placebo 250 mg

Interventions

Isomyosamine 250mg DRUG

Isomyosamine 250 mg capsules dosed 4 times daily

Study Drug: 1000 mg Isomyosamine

Placebo 250 mg DRUG

Placebo 250 mg capsule 4 times daily

Placebo 1000 mg

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• TNF Pharmaceuticals, Inc.: lead

Related Links

• Related Info

MeSH Terms

Conditions

Frailty; Sarcopenia; Hip Fractures; Femoral Fractures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Central Study Contacts

Dan Mazzucco

CONTACT

dmazzucco@3-e-a.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 24, 2025
• Study Start: May 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share