MF-300 for Treatment of Age-Related Sarcopenia
NCT07921420, Phase 2, Not yet recruiting, Epirium Bio Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | MF-300 for Treatment of Age-Related Sarcopenia | ClinicalTrials.gov |
| NCT number | NCT07921420 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 225 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Epirium Bio Inc. | ClinicalTrials.gov |
| Conditions | Sarcopenia in Elderly | ClinicalTrials.gov |
| Interventions | MF-300, Placebo, MF-300 | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 5-times chair stand test (5xCST) | Baseline, Week 12, and Week 24 | Change from baseline in physical performance as measured by the time (seconds \[sec\]) to complete the 5xCST | ClinicalTrials.gov |
| Secondary | Short Physical Performance Battery (SPPB) | Baseline, Week 12, and Week 24 | Change from baseline in physical performance as measured by the SPPB total score | ClinicalTrials.gov |
| Secondary | Handgrip strength | Baseline, Week 12, and Week 24 | Change from baseline in muscle strength as measured by handgrip strength test (kg) | ClinicalTrials.gov |
| Secondary | Gait Speed | Baseline, Week 12, and Week 24 | Change from baseline in mobility as measured by the usual gait speed (meter/sec) over 4 meters | ClinicalTrials.gov |
| Secondary | Patient Reported Outcomes Measurement Information System - Physical Function (PROMIS-PF-8d) | Baseline, Week 12, and Week 24 | 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. | ClinicalTrials.gov |
| Secondary | Sarcopenia and Quality of Life (SarQoL) | Baseline, Week 12, and Week 24 | 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. | ClinicalTrials.gov |
| Secondary | Patient Global Impression of Change (PGIC) | Baseline, Week 12, and Week 24 | 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. | ClinicalTrials.gov |
| Secondary | Patient Global Impression of Severity (PGIS) | Baseline, Week 12, Week 24 | 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. | ClinicalTrials.gov |
| Secondary | Appendicular skeletal muscle index (ASMI) | Baseline and Week 24 | Change from baseline in the ASMI as measured by dual-energy x-ray absorptiometry (DXA). | ClinicalTrials.gov |
| Secondary | Bone mineral density (BMD) | Baseline and Week 24 | Change from baseline in the BMD at the total hip, lumbar spine, and forearm as measured by DXA. | ClinicalTrials.gov |
| Secondary | Occurrence of Falls | up to Week 24 | The number of falls post-baseline | ClinicalTrials.gov |
| Secondary | Physical Activity | Baseline, Week 12, and Week 24 | 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). | ClinicalTrials.gov |
| Secondary | Muscle mass as measured by computed tomography (CT) | Baseline and Week 24 | 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. | ClinicalTrials.gov |
| Secondary | Isometric knee extension peak torque | Baseline, Week 12, and Week 24 | Change from baseline in the isometric knee extension peak torque (Newton meter \[Nm\]) (only at select sites with capability) | ClinicalTrials.gov |
| Secondary | Isometric knee extension time to peak torque | Baseline, Week 12, and Week 24 | Change from baseline in the isometric knee extension time to peak torque (sec) (only at select sites with capability) | ClinicalTrials.gov |
| Secondary | Isometric knee extension rate of torque development | Baseline, Week 12, and Week 24 | Change from baseline in the isometric knee extension rate of torque development (Nm/sec) (only at select sites with capability) | ClinicalTrials.gov |
| Secondary | Isokinetic knee extension peak torque through range of motion | Baseline, Week 12, and Week 24 | 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) | ClinicalTrials.gov |
| Secondary | Isokinetic knee extension average and peak power | Baseline, Week 12, and Week 24 | 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) | ClinicalTrials.gov |
| Secondary | Safety and Tolerability of MF-300 | up to Week 28 | Proportion of Participants with treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)