Sarcopenia in ElderlyPhase 2NCT07668180
A Study to Evaluate the Efficacy and Safety of IN-207907 Injection in Elderly Patients With Sarcopenia
A Phase 2 study testing IN-207907 120 mg, IN-207907 240 mg and IN-207907 360 mg in people with Sarcopenia in Elderly, run by HK inno.N Corporation.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia in Elderly
- What is being tested?
- IN-207907 120 mg, IN-207907 240 mg and IN-207907 360 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- IN-207907 120 mg, IN-207907 240 mg, IN-207907 360 mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IN-207907 120 mgDrug
IN-207907 120 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
IN-207907 240 mgDrug
IN-207907 240 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
IN-207907 360 mgDrug
IN-207907 360 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
PlaceboDrug
Placebo will be administered by intravenous injection at 4-week intervals for a total of 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| IN-207907 120 mg | Experimental | Not described Receives: Drug: IN-207907 120 mg |
| IN-207907 240 mg | Experimental | Not described Receives: Drug: IN-207907 240 mg |
| IN-207907 360 mg | Experimental | Not described Receives: Drug: IN-207907 360 mg |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Short Physical Performance Battery (SPPB) total score
Range 0-12, higher scores indicate better physical performance
Measured: From baseline to week 12
Secondary outcomes (13)
Change in the Short Physical Performance Battery (SPPB) total score
Range 0-12, higher scores indicate better physical performance
Measured: From baseline to week 4 and 8
Change in time to complete the 4-Meter Walk Test (4MWT)
Measured in seconds, lower values indicate better performance
Measured: From baseline to week 4, 8 and 12
Change in time to complete the 5 Times Chair Stand Test
Measured in seconds, lower values indicate better performance
Measured: From baseline to week 4, 8 and 12
Change in time to complete the Timed Up and Go (TUG) test
Measured in seconds, lower values indicate better performance
Measured: From baseline to week 4, 8 and 12
Change in handgrip strength measured using a digital hand dynamometer
In kilograms, higher values indicate greater muscle strength
Measured: From baseline to week 4, 8 and 12
Change in Appendicular Skeletal muscle Mass (ASM) as measured by Dual-energy X-ray Absorptiometry (DEXA)
Measured: 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
Range 0-10; higher scores indicate worse sarcopenia risk
Measured: From baseline to week 12
Change in the total score of the Sarcopenia Quality of Life (SarQoL) questionnaire
Range 0-100, higher scores indicate better quality of life
Measured: From baseline to week 12
Change in proportion of FoxP3+ regulatory T cells
Measured as %
Measured: From baseline to week 4, 8 and 12
Change in serum interleukin-6 (IL-6) concentration
Measured in pg/mL
Measured: From baseline to week 4, 8 and 12
Change in serum insulin-like growth factor-1 (IGF-1) concentration
Measured in ng/mL
Measured: From baseline to week 4, 8 and 12
Change in high-sensitivity C-reactive protein (hs-CRP) level
Measured in mg/L
Measured: From baseline to week 4, 8 and 12
Exercise and dietary compliance rate
Measured: From baseline to week 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jae-Young Lim, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668180
- Sponsor's protocol ID
- IN_TRA_201
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07668180
- Acronym / sponsor ID
- IN_TRA_201
- Conditions
- Sarcopenia in Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IN-207907 120 mgIN-207907 120 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses. | Drug | IN-207907 120 mg |
| IN-207907 240 mgIN-207907 240 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses. | Drug | IN-207907 240 mg |
| IN-207907 360 mgIN-207907 360 mg will be administered by intravenous injection at 4-week intervals for a total of 3 doses. | Drug | IN-207907 360 mg |
| PlaceboPlacebo will be administered by intravenous injection at 4-week intervals for a total of 3 doses. | Drug | Placebo |
Primary outcome
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
13 secondary outcomes
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
Exercise and dietary compliance rate
Time frame: From baseline to week 4, 8 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jae-Young Lim principal investigator
Seoul National University Bundang Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IN-207907 120 mg, IN-207907 240 mg and IN-207907 360 mg in people with Sarcopenia in Elderly, run by HK inno.N Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yujin Choi (+82 31-5176-4668, yujin.choi@inno-n.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Short Physical Performance Battery (SPPB) total score (time frame: From baseline to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.