NCT06942182

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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: TNF Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Isomyosamine 250mg	Isomyosamine 250 mg capsules dosed 4 times daily
DRUG	Placebo 250 mg	Placebo 250 mg capsule 4 times daily

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-04-24
• Last updated: 2025-04-24

Regulatory

• FDA-regulated drug study