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

NCT07668180 | Not Yet Recruiting Phase 2

• 1 other identifier: IN_TRA_201
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sarcopenia in Elderly

Outcome Measures

Primary Outcomes (1)

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

  Range 0-12, higher scores indicate better physical performance

  From baseline to week 12

Secondary Outcomes (13)

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

  From baseline to week 4 and 8

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

  From baseline to week 4, 8 and 12

• Change in time to complete the 5 Times Chair Stand Test

  From baseline to week 4, 8 and 12

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

  From baseline to week 4, 8 and 12

• Change in handgrip strength measured using a digital hand dynamometer

  From baseline to week 4, 8 and 12

Study Arms (4)

IN-207907 120 mg

EXPERIMENTAL

Drug: IN-207907 120 mg

IN-207907 240 mg

EXPERIMENTAL

Drug: IN-207907 240 mg

IN-207907 360 mg

EXPERIMENTAL

Drug: IN-207907 360 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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 120 mg

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 240 mg

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.

IN-207907 360 mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Officials

• Jae-Young Lim

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujin Choi

CONTACT

+82 31-5176-4668; yujin.choi@inno-n.com

Ahrong Kim

CONTACT

+82 31-5176-4666; ahrong.kim@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 25, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share