Sarcopenia in Elderly
Conditions
Brief summary
The goal of this clinical trial is to learn if intervention can treat sarcopenia in the elderly. Researchers will compare IN-207907 120 mg, 240 mg, 360 mg and placebo to see if SPPB score improves.
Interventions
DRUGIN-207907 120 mg
IN-207907 120 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
DRUGIN-207907 240 mg
IN-207907 240 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
DRUGIN-207907 360 mg
IN-207907 360 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
DRUGPlacebo
Placebo will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged ≥ 65 years (for female subjects, those who are medically unable to become pregnant) * Subjects diagnosed with sarcopenia in accordance with the Korean Working Group on Sarcopenia (KWGS) guidelines * Subjects with a body weight of ≥ 35 kg and a body mass index (BMI) of ≥ 15 kg/m² and \< 30 kg/m² * Subjects with a nutritional status screening score of ≥ 8 as assessed by the Mini Nutritional Assessment (MNA) questionnaire
Exclusion criteria
* Subjects with a history of diseases or surgical procedures that may affect physical activity or function * Subjects with underlying muscle disorders, including myopathy or muscular atrophy * Subjects with neuromuscular or neurological disorders * Subjects with uncontrolled diabetes mellitus, severe renal impairment, uncontrolled thyroid disorders, vitamin D deficiency, severe hepatic impairment, severe cardiac disease, uncontrolled hypertension, respiratory disorders * Subjects with clinically significant findings on a 12-lead electrocardiogram (ECG) * Subjects who are positive for active hepatitis B, active hepatitis C, syphilis, or human immunodeficiency virus * Subjects with a history of malignancy within 5 years * Subjects who have received systemic immunosuppressants or immunostimulants * Subjects who have undergone treatment with plasmapheresis within 8 weeks * Subjects who have received treatment with medications prohibited in this clinical trial within 4 weeks * Subjects with hemoglobin levels \< 10 g/dL * Subjects who have undergone surgery requiring general anesthesia within 4 weeks * Subjects who are unable to walk or are physically inactive * Subjects who are participating in or planning to participate in a separate high-intensity program for increasing muscle mass or strength during the clinical trial period * Subjects with severe psychiatric disorders such as major depression, schizophrenia, alcoholism, or drug dependence * Subjects with a score of \< 24 on the Korean version of the Mini Mental State Examination (MMSE-K) * Subjects with known allergies or hypersensitivity to the investigational product or its excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Short Physical Performance Battery (SPPB) total score | From baseline to week 12 | Range 0-12, higher scores indicate better physical performance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Short Physical Performance Battery (SPPB) total score | From baseline to week 4 and 8 | Range 0-12, higher scores indicate better physical performance |
| Change in time to complete the 4-Meter Walk Test (4MWT) | From baseline to week 4, 8 and 12 | Measured in seconds, lower values indicate better performance |
| Change in time to complete the 5 Times Chair Stand Test | From baseline to week 4, 8 and 12 | Measured in seconds, lower values indicate better performance |
| Change in time to complete the Timed Up and Go (TUG) test | From baseline to week 4, 8 and 12 | Measured in seconds, lower values indicate better performance |
| Change in handgrip strength measured using a digital hand dynamometer | From baseline to week 4, 8 and 12 | In kilograms, higher values indicate greater muscle strength |
| Change in Appendicular Skeletal muscle Mass (ASM) as measured by Dual-energy X-ray Absorptiometry (DEXA) | From baseline to week 12 | — |
| Change in the total score of the Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire | From baseline to week 12 | Range 0-10; higher scores indicate worse sarcopenia risk |
| Change in the total score of the Sarcopenia Quality of Life (SarQoL) questionnaire | From baseline to week 12 | Range 0-100, higher scores indicate better quality of life |
| Change in proportion of FoxP3+ regulatory T cells | From baseline to week 4, 8 and 12 | Measured as % |
| Change in serum interleukin-6 (IL-6) concentration | From baseline to week 4, 8 and 12 | Measured in pg/mL |
| Change in serum insulin-like growth factor-1 (IGF-1) concentration | From baseline to week 4, 8 and 12 | Measured in ng/mL |
| Change in high-sensitivity C-reactive protein (hs-CRP) level | From baseline to week 4, 8 and 12 | Measured in mg/L |
| Exercise and dietary compliance rate | From baseline to week 4, 8 and 12 | — |
Contacts
CONTACTYujin Choi
CONTACTAhrong Kim
PRINCIPAL_INVESTIGATORJae-Young Lim
Seoul National University Bundang Hospital
Outcome results
None listed