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NCT Number: NCT07668180

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IN-207907 120 mg

Drug

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

IN-207907 240 mg

Drug

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

IN-207907 360 mg

Drug

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

Placebo

Drug

Placebo will be administered by intravenous injection at 4-week intervals for a total of 3 doses.

Primary outcomes

  1. Change in the Short Physical Performance Battery (SPPB) total score

    Time frame: From baseline to week 12

    Range 0-12, higher scores indicate better physical performance

Secondary outcomes

  1. Change in the Short Physical Performance Battery (SPPB) total score

    Time frame: From baseline to week 4 and 8

    Range 0-12, higher scores indicate better physical performance

  2. Change in time to complete the 4-Meter Walk Test (4MWT)

    Time frame: From baseline to week 4, 8 and 12

    Measured in seconds, lower values indicate better performance

  3. Change in time to complete the 5 Times Chair Stand Test

    Time frame: From baseline to week 4, 8 and 12

    Measured in seconds, lower values indicate better performance

  4. Change in time to complete the Timed Up and Go (TUG) test

    Time frame: From baseline to week 4, 8 and 12

    Measured in seconds, lower values indicate better performance

  5. Change in handgrip strength measured using a digital hand dynamometer

    Time frame: From baseline to week 4, 8 and 12

    In kilograms, higher values indicate greater muscle strength

  6. Change in Appendicular Skeletal muscle Mass (ASM) as measured by Dual-energy X-ray Absorptiometry (DEXA)

    Time frame: From baseline to week 12

  7. 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

    Range 0-10; higher scores indicate worse sarcopenia risk

  8. Change in the total score of the Sarcopenia Quality of Life (SarQoL) questionnaire

    Time frame: From baseline to week 12

    Range 0-100, higher scores indicate better quality of life

  9. Change in proportion of FoxP3+ regulatory T cells

    Time frame: From baseline to week 4, 8 and 12

    Measured as %

  10. Change in serum interleukin-6 (IL-6) concentration

    Time frame: From baseline to week 4, 8 and 12

    Measured in pg/mL

  11. Change in serum insulin-like growth factor-1 (IGF-1) concentration

    Time frame: From baseline to week 4, 8 and 12

    Measured in ng/mL

  12. Change in high-sensitivity C-reactive protein (hs-CRP) level

    Time frame: From baseline to week 4, 8 and 12

    Measured in mg/L

  13. Exercise and dietary compliance rate

    Time frame: From baseline to week 4, 8 and 12

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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