A Study to Evaluate the Efficacy and Safety of IN-207907 Injection in Elderly Patients With Sarcopenia

Официальное название

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy and Safety of IN-207907 Injection in Elderly Patients With Sarcopenia

Обзор

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.

Вмешательства

• Препарат IN-207907 120 mg
  IN-207907 120 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
• Препарат IN-207907 240 mg
  IN-207907 240 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
• Препарат IN-207907 360 mg
  IN-207907 360 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
• Препарат Placebo
  Placebo will be administered by intravenous injection at 4-week intervals for a total of 3 doses.

Первичные конечные точки

• Change in the Short Physical Performance Battery (SPPB) total score [Срок оценки: From baseline to week 12]

Вторичные конечные точки (12)

• Change in the Short Physical Performance Battery (SPPB) total score [Срок оценки: From baseline to week 4 and 8]
• Change in time to complete the 4-Meter Walk Test (4MWT) [Срок оценки: From baseline to week 4, 8 and 12]
• Change in time to complete the 5 Times Chair Stand Test [Срок оценки: From baseline to week 4, 8 and 12]
• Change in time to complete the Timed Up and Go (TUG) test [Срок оценки: From baseline to week 4, 8 and 12]
• Change in handgrip strength measured using a digital hand dynamometer [Срок оценки: From baseline to week 4, 8 and 12]
• Change in Appendicular Skeletal muscle Mass (ASM) as measured by Dual-energy X-ray Absorptiometry (DEXA) [Срок оценки: 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 [Срок оценки: From baseline to week 12]
• Change in the total score of the Sarcopenia Quality of Life (SarQoL) questionnaire [Срок оценки: From baseline to week 12]
• Change in proportion of FoxP3+ regulatory T cells [Срок оценки: From baseline to week 4, 8 and 12]
• Change in serum interleukin-6 (IL-6) concentration [Срок оценки: From baseline to week 4, 8 and 12]
• Change in serum insulin-like growth factor-1 (IGF-1) concentration [Срок оценки: From baseline to week 4, 8 and 12]
• Change in high-sensitivity C-reactive protein (hs-CRP) level [Срок оценки: From baseline to week 4, 8 and 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07668180 · IN_TRA_201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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