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

Official title

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

Overview

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

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

Primary outcome measures

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

Secondary outcome measures (12)

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07668180 · IN_TRA_201

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗