Sarcopenia in ElderlyPhase 2NCT06942182
Safety and Efficacy of Isomyosamine in Reducing Inflammation and Treating Muscle Loss in Older Adults After Hip or Thigh Bone Fractures
A Phase 2 study testing Isomyosamine 250mg in people with Sarcopenia in Elderly and Frailty, run by TNF Pharmaceuticals, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Sarcopenia in Elderly, Frailty, Frailty/Sarcopenia
- What is being tested?
- Isomyosamine 250mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 Mar 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dan Mazzucco contact
About this study
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
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.
- Being tested
- Isomyosamine 250mg, Placebo 250 mg
- Keywords
- sarcopenia, Frailty, Hip Fracture, Older population, Gerontological, Femur fracture, Sarcopenia and Frailty
- Medical subject headings
- Frailty, Sarcopenia, Hip Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isomyosamine 250mgDrug
Isomyosamine 250 mg capsules dosed 4 times daily
Placebo 250 mgDrug
Placebo 250 mg capsule 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| Study Drug: 1000 mg Isomyosamine | Experimental | Subjects randomly assigned to receive 1000 mg Isomyosamine daily via four 250 mg capsules Receives: Drug: Isomyosamine 250mg |
| Placebo 1000 mg | Placebo comparator | Subjects randomly assigned to receive 1000 mg placebo daily via four 250 mg capsules Receives: Drug: Placebo 250 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery (SPPB) Test in subjects treated with Isomyosamine or placebo
Measured: From enrollment to the end of treatment at 90 days
Secondary outcomes (5)
4-meter walk test
Change in the time taken to walk 4 meters through 90 days dosing.
Measured: From enrollment to the end of treatment at 90 days
6-minute walk test
Change in the distance walked in the 6-minute walk test (m) through 90 days dosing.
Measured: From enrollment to the end of treatment at 90 days
Grip strength
Change in grip strength score over 90 day dosing.
Measured: From enrollment to the end of treatment at 90 days
Effect on serum levels of biochemical markers of TNF activation
Measured: 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
Measured: From enrollment to the end of treatment at 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TNF Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942182
- Sponsor's protocol ID
- TNF001
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06942182
- Acronym / sponsor ID
- TNF001
- Keywords
- sarcopenia, Frailty, Hip Fracture, Older population, Gerontological, Femur fracture, Sarcopenia and Frailty
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- TNF Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Drug: 1000 mg Isomyosamine | Experimental | Drug: Isomyosamine 250mgSubjects randomly assigned to receive 1000 mg Isomyosamine daily via four 250 mg capsules |
| Placebo 1000 mg | Placebo comparator | Drug: Placebo 250 mgSubjects randomly assigned to receive 1000 mg placebo daily via four 250 mg capsules |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isomyosamine 250mgIsomyosamine 250 mg capsules dosed 4 times daily | Drug | Study Drug: 1000 mg Isomyosamine |
| Placebo 250 mgPlacebo 250 mg capsule 4 times daily | Drug | Placebo 1000 mg |
Primary outcome
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
5 secondary outcomes
4-meter walk test
Time frame: 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
Grip strength
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Mazzucco contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Isomyosamine 250mg in people with Sarcopenia in Elderly and Frailty, run by TNF Pharmaceuticals, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Mazzucco (dmazzucco@3-e-a.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.