Sarcopenia in ElderlyPhase 2NCT07921420
MF-300 for Treatment of Age-Related Sarcopenia
A Phase 2 study testing MF-300 in people with Sarcopenia in Elderly, run by Epirium Bio Inc..
Trial summary
This Phase 2b clinical trial will evaluate whether MF-300 can improve physical function and muscle strength and assess its safety in adults aged 65 years and older with sarcopenia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- MF-300
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Sep 2028
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects must meet all of the following criteria to be eligible for participation in the study:
- 1. Capable of giving signed informed consent that includes agreement to comply with the requirements described in the informed consent form (ICF) and in this protocol.
- 2. Male or non-pregnant, non-lactating female aged ≥65 years old at the time of signing the informed consent.
- 3. Presence of sarcopenia as defined by the Sarcopenia Definitions and Outcomes Consortium (SDOC) at Screening and Baseline
- a. Low grip strength: <35.5 kg for male; <20 kg for female using JAMAR hydraulic handheld isometric dynamometer AND
- b. Slowness: usual gait speed over 4 meters of <0.8 m/s
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- 4. Total Short Physical Performance Battery (SPPB) score within the range of 4 - 8 points (inclusive) at Screening and Baseline with a time to complete the 5xCSTof ≥14.0 to ≤40.0 seconds.
- 5. Female subjects must have no childbearing potential.
- 6. Male subjects must be non-fertile, vasectomized (vasectomy performed 4 months or more prior to the first dosing), or truly abstinent of heterosexual intercourse and agree to remain abstinent for duration of study and for 30 days from last administration of Study Drug, or heterosexual partner is not of child bearing potential, or subject is willing to continue using 2 medically acceptable forms of birth control from Day -1 until at least 30 days after the last administration of Study Drug.
- 7. Body mass index (BMI) ≤35.0 kg/m2.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from participating in the study:
- 1. History of a pelvic or lower limb fracture (e.g., femur, tibia) within the past 6 months with persistent negative impact on lower extremity function or any significant impairment or disease adversely impacting gait. Individuals with hip and/or knee replacement performed >12 months prior to Screening are eligible for enrollment if their activity status has stabilized.
- 2. Presence of distal upper extremity impairment either due to prior recent injury or disease (e.g., tenosynovitis, rheumatoid arthritis).
- 3. Presence of acute immobility post-acute hospital admission.
- 4. Confirmed diagnosis of significant psychiatric disease (e.g., dementia/Alzheimer's disease, schizophrenia, severe depression or bipolar disorder). Individuals with adequately treated depression are eligible for enrollment.
- 5. Neurological injury/disorder with significant persistent functional deficit (e.g., stroke with hemiparesis, spinal cord injury, muscular dystrophy, multiple sclerosis, polymyositis, dermatomyositis, myopathy/myositides, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy).
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- 6. Intraocular surgery and laser procedures for refractive correction within 6 months prior to Screening.
- 7. Known history of glaucoma or evidence suggestive of glaucoma at Screening, including elevated intraocular pressure as measured by tonometry, as determined by the Investigator.
- 8. Vitamin D deficiency defined as 25-OH-vitamin D levels <8.0 ng/mL (20 nmol/L).
- 9. Hemoglobin concentration below 11.0 g/dL (110 g/L) for males or below 10.0 g/dL (100 g/L) for females at Screening.
- 10. Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m2 calculated by central lab using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) cystatin C equation.
- 11. History of confirmed chronic obstructive pulmonary disease with a severity Grade >2 on the Medical Research Council Dyspnea Scale.
- 12. Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/day prednisone equivalent, acquired immunodeficiency syndrome (AIDS), medically confirmed diagnosis of chronic fatigue syndrome, long COVID, or type 1 diabetes mellitus.
- 13. History of or ongoing gastrointestinal (GI) conditions (e.g., active and chronic colitis, small or large bowel resection, gastric bypass or equivalent) that would interfere with drug tolerance or absorption.
- 14. Abnormal liver function tests such as aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or serum bilirubin (except Gilbert's Disease) determined based on the following criteria:
- a. Any single transaminase may not exceed 3x the upper limit of normal (ULN). A single parameter elevated up to and including 3x ULN should be re-checked as soon as possible, and always prior to enrollment/randomization, to rule out any lab error.
- b. If the total bilirubin level is above the ULN, total bilirubin should be differentiated into the direct and indirect reacting bilirubin. In any case, total bilirubin should not exceed the value of 1.6 mg/dL.
- 15. Platelet count <75,000/mm3.
- 16. Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis) or conditions with hepatotoxic potential (e.g., known gallbladder or bile duct disease, acute or chronic pancreatitis).
- 17. Confirmed diagnosis of heart failure classified as New York Heart Association Class III and IV (e.g., dilated cardiomyopathy).
- 18. Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g., angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of Screening. Subjects with current/active unstable angina are excluded.
- 19. Severe cardiac valve disorders or defects (e.g., aortic or mitral stenosis).
- 20. Severe pulmonary hypertension uncontrolled with medication.
- 21. Clinically significant cardiac arrhythmia requiring medical intervention in the past 3 months prior to Screening (e.g., supraventricular tachycardia, atrial fibrillation with rapid ventricular rate, automated implantable cardioverter defibrillator with discharge).
- 22. Chest pain, severe shortness of breath, or occurrence of other safety concerns during the screening or assessments.
- 23. Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years except for nonmelanoma skin cancers or cancers with excellent prognosis (e.g., early-stage prostate or breast cancer, carcinoma in situ of the uterine cervix).
- 24. Active systemic infection requiring hospitalization or treatment with intravenous anti-infectives or antibiotics within 4 weeks of Screening or randomization.
- 25. Any chronic active infection (e.g., human immunodeficiency virus [HIV], hepatitis B or C, tuberculosis, etc.), to be confirmed prior to randomization. Subjects receiving chemoprophylaxis for latent tuberculosis infection are eligible for the study.
- 26. Active alcohol/drug abuse, or alcohol/drug treatment <12 months prior to Screening; subjects having successfully completed an alcohol/drug treatment program >12 months prior to Screening with sustained abstinence are eligible.
- 27. Individuals who require routine and regular (e.g., daily) assistance from another person to complete one or more basic activities of daily living (ADL) (e.g., bathing, dressing, toileting, feeding, grooming) regardless of where they reside. Assistance with instrumental ADL (e.g., shopping, meal preparation, housework) is permitted.
- 28. Mini Mental State Examination score <24 at Screening.
- 29. Presence of severe malnutrition determined by Mini Nutritional Assessment®-Short Form (MNA®-SF) score ≤9.
- 30. Poorly controlled blood pressure defined as systolic blood pressure >180 or <80 mmHg or diastolic blood pressure >100 or <40 mmHg at Screening or randomization.
- 31. Uncontrolled type 2 diabetes mellitus (i.e., hemoglobin A1c [HbA1c] >8.5% or frequent hypoglycemia).
- 32. Uncontrolled or insufficiently managed hypothyroidism or hyperthyroidism. Hypothyroid subjects who are not on a stable dose of thyroid hormone replacement therapy or have changed the dose of thyroid hormone replacement therapy within the 6 weeks prior to Screening are not eligible for the study.
- 33. Participation in another investigational drug, biologic, or device study, with less than 30 days or less than 5 half-lives from the last dose of investigational product to randomization, whichever is longer, or any other type of medical research judged to be scientifically or medically incompatible with this study.
- 34. Use of any therapies known to affect muscle mass, including androgens, androgen supplements [including over-the-counter dehydroepiandrosterone (DHEA)], gonadotropin releasing hormone (GnRH) analogues, anti-androgens, anti-estrogens (e.g., tamoxifen), progestins with known androgenic component (e.g., norethindrone acetate, megestrol acetate, high-dose tibolone [2.5 mg]), recombinant human growth hormone, growth hormone receptor antagonists (e.g., pregvisomant), oral selective beta-2 agonists, dronabinol or any nutritional supplement other than protein marketed as a muscle anabolic within 3 months prior to Screening.
- 35. Use of any anabolic steroids (e.g., testosterone) within 3 months prior to Screening.
- 36. Use of glucagon-like peptide-1 (GLP-1) receptor agonist or GLP-1/GIP dual agonist therapy for any indication (e.g., obesity, type 2 diabetes mellitus, or metabolic dysfunction-associated steatohepatitis [MASH]) within the 6 months prior to Screening.
- 37. Systemic corticosteroid use for at least 3 months (in the last year) prior to Screening at a daily dose greater than 10 mg prednisone equivalent.
- 38. Use of non-antibody immunosuppressive therapy (e.g., cyclosporine, methotrexate, tacrolimus, cyclophosphamide) within 3 months of Screening.
- 39. Chronic use of a beta blocker initiated within the 3 months prior to Screening.
- 40. Chronic use (continuous use >7 days) of acetaminophen or cyclooxygenase (COX)-1 and/or COX-2 inhibitors (e.g., aspirin, other nonsteroidal anti-inflammatory drugs [NSAIDs] such as ibuprofen, naproxen, diclofenac, or celecoxib) within the 3 weeks of Day 1 and unable to refrain from chronic use over the course of the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MF-300 in Subjects With Age-related Sarcopenia
This Phase 2b clinical trial will evaluate whether MF-300 can improve physical function and muscle strength and assess its safety in adults aged 65 years and older with sarcopenia. The study will also evaluate how MF-300 is processed by the body and its effects on measures related to muscle health, quality of life, and physical activity.
Participants will receive MF-300 or placebo once daily for 24 weeks. The study includes an initial open-label part evaluating MF-300 followed by a randomized, placebo-controlled part evaluating two dose levels of MF-300.
Read the detailed description
Sarcopenia is a progressive and generalized skeletal muscle disorder associated with loss of muscle strength, physical performance, and quality of life in older adults.
This Phase 2b, multicenter study will evaluate the efficacy and safety of MF-300 administered orally once daily (QD) for 24 weeks in subjects aged ≥65 years with age-related sarcopenia. MF-300 is an investigational inhibitor of 15-hydroxyprostaglandin dehydrogenase, an enzyme that degrades prostaglandin E2, a signaling molecule involved in the repair and regeneration of skeletal muscle. This study will consist of 2 parts.
Part A will enroll approximately 25 participants in an open-label evaluation of MF-300 75 mg once daily for 24 weeks. Part A is designed to characterize the efficacy, safety and pharmacokinetics (PK) of MF-300 in the target patient population and to provide additional clinical experience prior to initiation of Part B.
Part B will enroll approximately 200 participants who will be randomized 1:1:1 to receive MF-300 75 mg, MF-300 200 mg, or placebo once daily for 24 weeks. Part B will evaluate the efficacy and safety of the two MF-300 dose levels compared with placebo.
The study will assess multiple aspects of physical function, muscle strength, and Quality of Life (QOL). Assessments will include the 5-times chair stand test (5xCST), 4-meter gait speed, Short Physical Performance Battery (SPPB), handgrip strength, and knee extensor strength. Patient-reported assessments will evaluate physical function, the impact of sarcopenia on quality of life, and participants' overall perception of symptom severity.
Physical activity and functional movement during daily living will also be assessed using a wearable device equipped with digital health technology. Falls will be monitored throughout the study.
Safety will be assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.
- Conditions
- Sarcopenia in Elderly
- Being tested
- MF-300, Placebo
- Keywords
- MF-300, Sarcopenia, Elderly
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MF-300Drug
oral tablet at doses of 75mg
PlaceboDrug
matching placebo oral tablet
MF-300Drug
oral tablet at doses of 200 mg
| Study group | Role | What they receive |
|---|---|---|
| Part A: MF-300 75 mg | Experimental | 75 mg MF-300 administered orally once daily for 24 weeks in Part A Receives: Drug: MF-300 |
| Part B: MF-300 75 mg | Experimental | 75 mg MF-300 administered orally once daily for 24 weeks in Part B Receives: Drug: MF-300 |
| Part B: MF-300 200 mg | Experimental | 200 mg MF-300 administered orally once daily for 24 weeks in Part B Receives: Drug: MF-300 |
| Part B: Placebo | Placebo comparator | Matching placebo administered orally once daily for 24 weeks in Part B Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-times chair stand test (5xCST)
Change from baseline in physical performance as measured by the time (seconds [sec]) to complete the 5xCST
Measured: Baseline, Week 12, and Week 24
Secondary outcomes (18)
Short Physical Performance Battery (SPPB)
Change from baseline in physical performance as measured by the SPPB total score
Measured: Baseline, Week 12, and Week 24
Handgrip strength
Change from baseline in muscle strength as measured by handgrip strength test (kg)
Measured: Baseline, Week 12, and Week 24
Gait Speed
Change from baseline in mobility as measured by the usual gait speed (meter/sec) over 4 meters
Measured: Baseline, Week 12, and Week 24
Patient Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF-8d)
Change from baseline in the PROMIS-PF-8d questionnaire. PROMIS-PF-8d consists of 8 questions assessing subjects' physical functions. A higher score indicates better physical functioning.
Measured: Baseline, Week 12, and Week 24
Sarcopenia and Quality of Life (SarQoL)
Change from Baseline in the SarQoL questionnaire. The questionnaire addresses 7 domains of health-related quality of life; Physical and Mental Health, Locomotion, Body Composition, Functionality, ADL, Leisure activities, and Fears, and is scored through a scoring algorithm on 100 points, with higher scores reflecting a better quality of life.
Measured: Baseline, Week 12, and Week 24
Patient Global Impression of Change (PGIC)
Change from baseline in the PGIC questionnaire. The PGIC is a single-item, patient-reported measure that evaluates the patient's perception of change in their condition since the start of study treatment. Subjects rate their overall change using a standardized categorical scale.
Measured: Baseline, Week 12, and Week 24
Patient Global Impression of Severity (PGIS)
Change from baseline in the PGIS questionnaire. The PGIS is a single-item, patient-reported measure that evaluates the patient's perception of severity in their condition. Subjects rate their overall change using a standardized categorical scale.
Measured: Baseline, Week 12, Week 24
Appendicular skeletal muscle index (ASMI)
Change from baseline in the ASMI as measured by dual-energy x-ray absorptiometry (DXA).
Measured: Baseline and Week 24
Bone mineral density (BMD)
Change from baseline in the BMD at the total hip, lumbar spine, and forearm as measured by DXA.
Measured: Baseline and Week 24
Occurrence of Falls
The number of falls post-baseline
Measured: up to Week 24
Physical Activity
Change from baseline in physical activity and functional movement in daily living conditions as monitored by a wearable device equipped with digital health technology (DHT).
Measured: Baseline, Week 12, and Week 24
Muscle mass as measured by computed tomography (CT)
Change from baseline in cortical bone thickness as measured by CT in all subjects in Part A and subjects in Part B in the CT substudy only.
Measured: Baseline and Week 24
Isometric knee extension peak torque
Change from baseline in the isometric knee extension peak torque (Newton meter [Nm]) (only at select sites with capability)
Measured: Baseline, Week 12, and Week 24
Isometric knee extension time to peak torque
Change from baseline in the isometric knee extension time to peak torque (sec) (only at select sites with capability)
Measured: Baseline, Week 12, and Week 24
Isometric knee extension rate of torque development
Change from baseline in the isometric knee extension rate of torque development (Nm/sec) (only at select sites with capability)
Measured: Baseline, Week 12, and Week 24
Isokinetic knee extension peak torque through range of motion
Change from baseline in the isokinetic knee extension peak torque (Nm) through range of motion at 60 degrees/sec and 180 degrees/sec (only at select sites with capability)
Measured: Baseline, Week 12, and Week 24
Isokinetic knee extension average and peak power
Change from baseline in the isokinetic knee extension average and peak power (W) through range of motion at 60 degrees/sec and 180 degrees/sec (only at select sites with capability)
Measured: Baseline, Week 12, and Week 24
Safety and Tolerability of MF-300
Proportion of Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation
Measured: up to Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Sep 2028 (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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epirium Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921420
- Sponsor's protocol ID
- MF-300-201
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MF-300 in Subjects With Age-related Sarcopenia
- ClinicalTrials.gov ID
- NCT07921420
- Acronym / sponsor ID
- MF-300-201
- Conditions
- Sarcopenia in Elderly
- Keywords
- MF-300, Sarcopenia, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Epirium Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 6 Nov 2026 (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 2b clinical trial will evaluate whether MF-300 can improve physical function and muscle strength and assess its safety in adults aged 65 years and older with sarcopenia. The study will also evaluate how MF-300 is processed by the body and its effects on measures related to muscle health, quality of life, and physical activity.
Participants will receive MF-300 or placebo once daily for 24 weeks. The study includes an initial open-label part evaluating MF-300 followed by a randomized, placebo-controlled part evaluating two dose levels of MF-300.
Detailed description
Sarcopenia is a progressive and generalized skeletal muscle disorder associated with loss of muscle strength, physical performance, and quality of life in older adults.
This Phase 2b, multicenter study will evaluate the efficacy and safety of MF-300 administered orally once daily (QD) for 24 weeks in subjects aged ≥65 years with age-related sarcopenia. MF-300 is an investigational inhibitor of 15-hydroxyprostaglandin dehydrogenase, an enzyme that degrades prostaglandin E2, a signaling molecule involved in the repair and regeneration of skeletal muscle. This study will consist of 2 parts.
Part A will enroll approximately 25 participants in an open-label evaluation of MF-300 75 mg once daily for 24 weeks. Part A is designed to characterize the efficacy, safety and pharmacokinetics (PK) of MF-300 in the target patient population and to provide additional clinical experience prior to initiation of Part B.
Part B will enroll approximately 200 participants who will be randomized 1:1:1 to receive MF-300 75 mg, MF-300 200 mg, or placebo once daily for 24 weeks. Part B will evaluate the efficacy and safety of the two MF-300 dose levels compared with placebo.
The study will assess multiple aspects of physical function, muscle strength, and Quality of Life (QOL). Assessments will include the 5-times chair stand test (5xCST), 4-meter gait speed, Short Physical Performance Battery (SPPB), handgrip strength, and knee extensor strength. Patient-reported assessments will evaluate physical function, the impact of sarcopenia on quality of life, and participants' overall perception of symptom severity.
Physical activity and functional movement during daily living will also be assessed using a wearable device equipped with digital health technology. Falls will be monitored throughout the study.
Safety will be assessed throughout the study by monitoring adverse events, laboratory tests, vital signs, and physical examinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: MF-300 75 mg | Experimental | Drug: MF-30075 mg MF-300 administered orally once daily for 24 weeks in Part A |
| Part B: MF-300 75 mg | Experimental | Drug: MF-30075 mg MF-300 administered orally once daily for 24 weeks in Part B |
| Part B: MF-300 200 mg | Experimental | Drug: MF-300200 mg MF-300 administered orally once daily for 24 weeks in Part B |
| Part B: Placebo | Placebo comparator | Drug: PlaceboMatching placebo administered orally once daily for 24 weeks in Part B |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Subjects must meet all of the following criteria to be eligible for participation in the study:
- 1. Capable of giving signed informed consent that includes agreement to comply with the requirements described in the informed consent form (ICF) and in this protocol.
- 2. Male or non-pregnant, non-lactating female aged ≥65 years old at the time of signing the informed consent.
- 3. Presence of sarcopenia as defined by the Sarcopenia Definitions and Outcomes Consortium (SDOC) at Screening and Baseline
- a. Low grip strength: <35.5 kg for male; <20 kg for female using JAMAR hydraulic handheld isometric dynamometer AND
Key exclusion criteria (43 listed)
- Subjects who meet any of the following criteria will be excluded from participating in the study:
- 1. History of a pelvic or lower limb fracture (e.g., femur, tibia) within the past 6 months with persistent negative impact on lower extremity function or any significant impairment or disease adversely impacting gait. Individuals with hip and/or knee replacement performed >12 months prior to Screening are eligible for enrollment if their activity status has stabilized.
- 2. Presence of distal upper extremity impairment either due to prior recent injury or disease (e.g., tenosynovitis, rheumatoid arthritis).
- 3. Presence of acute immobility post-acute hospital admission.
- 4. Confirmed diagnosis of significant psychiatric disease (e.g., dementia/Alzheimer's disease, schizophrenia, severe depression or bipolar disorder). Individuals with adequately treated depression are eligible for enrollment.
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 |
|---|---|---|
| MF-300oral tablet at doses of 75mg | Drug | Part A: MF-300 75 mg, Part B: MF-300 75 mg |
| Placebomatching placebo oral tablet | Drug | Part B: Placebo |
| MF-300oral tablet at doses of 200 mg | Drug | Part B: MF-300 200 mg |
Primary outcome
5-times chair stand test (5xCST)
Time frame: Baseline, Week 12, and Week 24
Change from baseline in physical performance as measured by the time (seconds [sec]) to complete the 5xCST
18 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Baseline, Week 12, and Week 24
Handgrip strength
Time frame: Baseline, Week 12, and Week 24
Gait Speed
Time frame: Baseline, Week 12, and Week 24
Patient Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF-8d)
Time frame: Baseline, Week 12, and Week 24
Sarcopenia and Quality of Life (SarQoL)
Time frame: Baseline, Week 12, and Week 24
Patient Global Impression of Change (PGIC)
Time frame: Baseline, Week 12, and Week 24
Patient Global Impression of Severity (PGIS)
Time frame: Baseline, Week 12, Week 24
Appendicular skeletal muscle index (ASMI)
Time frame: Baseline and Week 24
Bone mineral density (BMD)
Time frame: Baseline and Week 24
Occurrence of Falls
Time frame: up to Week 24
Physical Activity
Time frame: Baseline, Week 12, and Week 24
Muscle mass as measured by computed tomography (CT)
Time frame: Baseline and Week 24
Isometric knee extension peak torque
Time frame: Baseline, Week 12, and Week 24
Isometric knee extension time to peak torque
Time frame: Baseline, Week 12, and Week 24
Isometric knee extension rate of torque development
Time frame: Baseline, Week 12, and Week 24
Isokinetic knee extension peak torque through range of motion
Time frame: Baseline, Week 12, and Week 24
Isokinetic knee extension average and peak power
Time frame: Baseline, Week 12, and Week 24
Safety and Tolerability of MF-300
Time frame: up to Week 28
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 6 Nov 2026.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MF-300 in people with Sarcopenia in Elderly, run by Epirium Bio 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 10 inclusion and 43 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 6 Nov 2026. 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 Epirium Bio Study Director (858-529-1010, clininquiries@epirium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-times chair stand test (5xCST) (time frame: Baseline, Week 12, and Week 24). 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 6 Nov 2026.