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NCT07668180
A Study to Evaluate the Efficacy and Safety of IN-207907 Injection in Elderly Patients With Sarcopenia
Conditions: Sarcopenia in Elderly
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: HK inno.N Corporation
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07668180). StuddyBuddy aggregates publicly available trial information.