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

ConditionSarcopenia in Elderly
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorHK inno.N Corporation

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: IN-207907 120 mgExperimental treatment 1 intervention
Group B: IN-207907 240 mgExperimental treatment 1 intervention
Group C: IN-207907 360 mgExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Range 0-12, higher scores indicate better physical performance

Time frame
From baseline to week 12

Secondary outcomes

1

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

Range 0-12, higher scores indicate better physical performance

Time frame
From baseline to week 4 and 8
2

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

Measured in seconds, lower values indicate better performance

Time frame
From baseline to week 4, 8 and 12
3

Change in time to complete the 5 Times Chair Stand Test

Measured in seconds, lower values indicate better performance

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

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

Measured in seconds, lower values indicate better performance

Time frame
From baseline to week 4, 8 and 12

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HK inno.N Corporation

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: