None listed
Conditions
Interventions
Drug : [Experimental] Take one tablet of KSB-10301(800mg) each morning and evening at a consistent time for 24 weeks
[Placebo Comparator] Take one placebo tablet(of KSB-10301) each morning and evening
Sponsors
KSB Tugen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 60 years and older 2) Diagnosed with sarcopenia based on the AWGS criteria, satisfying either (1) or (2) and (3) (1) ASM measured by DXA: <7.0 kg/m² for men, <5.4 kg/m² for women. (2) ASM measured by BIA: <7.0 kg/m² for men, <5.7 kg/m² for women. (3) HGS: <28 kg for men, <18 kg for women 3) Body weight of =35 kg and a body mass index(BMI) =30 kg/m² 4) Mini nutritional assessment(MNA) score = 8
Exclusion criteria
Exclusion criteria: 1) Participants with diseases or surgeries that have caused significant impairment in physical activities or function, such as walking, exercise, or efficacy assessments, within 24 weeks prior to screening (e.g., fractures, arthritis [limited to severe knee or hip arthritis], vascular diseases, neurological disorders, etc.). However, participants who have recovered physical activity and function to a Koval score of 1, as confirmed by the investigator, may be eligible. 2) Short Physical Performance Battery(SPPB) score =10 3) Neuromuscular or neurological disorders(e.g., Parkinson’s disease, amyotrophic lateral sclerosis (ALS), muscular dystrophy, multiple sclerosis, or other progressive diseases, as well as stroke, epilepsy, or other conditions affecting lower limb function). 4) Participants with underlying muscle disorders, including myopathies or muscular dystrophy, at the time of screening. 5) Severe heart diseases including heart failure(New York Heart Association (NYHA) class 3 or higher), acute coronary syndrome (unstable angina, acute myocardial infarction), clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmias deemed clinically significant by the investigator, peripheral vascular disease, hypertrophic obstructive cardiomyopathy, valvular heart disease, or aortic disease. 6) Malignancies within 5 years prior to screening(excluding non-melanoma skin cancers). 7) Participants who have undergone intraocular surgery or laser procedures for refractive correction within 6 months prior to screening. 8) Participants who have taken supplements related to muscle strength improvement (e.g., amino acids, creatine) or health functional foods within 2 weeks prior to screening. Participants who have used vitamin D at a dose exceeding 4,000 IU/day are also excluded unless they have been taking a consistent dose for at least 12 weeks prior to screening and are expected to maintain this dose until the end of the study. 9) Genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. 10) Chronic kidney disease [estimated glomerular filtration rate (eGFR) 8.5%) 12) Participants with a history of moderate to severe chronic obstructive pulmonary disease (COPD). 13) Participants with a history of severe active acute or chronic liver disease (e.g., cirrhosis). 14) Uncontrolled or inadequately managed thyroid disorders(e.g., hyperthyroidism or hypothyroidism). 15) Uncontrolled hypertension(SBP >180 mmHg or DBP >110 mmHg) or clinically significant hypotension(SBP <90 mmHg or DBP <50 mmHg). 16) Participants who consume more than 140 g of alcohol per week (equivalent to approximately 2.5 bottles of soju per week or 2.5 drinks per day). 17) Participants who have engaged in resistance exercise consistently within 12 weeks prior to screening [high-intensity body-building or strength-training programs involving resistance exercises with a subjective intensity rating of 7 or higher (e.g., dumbbell exercises more than 3 times per week)]. Regular physical activity is not restricted. 18) Participants with hypersensitivity or a history of hypersensitivity to oxiracetam or drugs of the same class (acetylcholine transmission enhancers). 19) Participants who have received or undergone treatment with investigational drugs or medical devices within 12 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Short Physical Performance Battery(SPPB) Test at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Short Physical Performance Battery(SPPB) Test at Week 12;Change From Baseline to Hand Grip Strength(HGS) at Week 12 and Week 24;Change From Baseline to Appendicular Skeletal Muscle(ASM) at Week 24;Change From Baseline to SarQoL Score at Week 12 and Week 24;Change From Baseline to SARC-F Score at Week 12 and Week 24 | — |
Countries
Korea, Republic of
Contacts
Public ContactJin-Young Shin
Konkuk University Medical Center
Outcome results
None listed