Muscle PerformancePhase 2NCT06600581
Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness
A Phase 2 study testing IMM01-STEM in people with Muscle Performance and Sarcopenic Obesity, run by Immunis, Inc. at 4 sites in United States.
Trial summary
Placebo controlled study for safety and efficacy of IMM01-STEM on muscle performance in seniors with obesity and muscle weakness Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Muscle Performance, Sarcopenic Obesity
- What is being tested?
- IMM01-STEM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Dec 2024to 15 Dec 2026
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex: male or female
- Age 60 to 80 years of age at the time of signing the informed consent.
- Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria
- Disease characteristics: To be eligible, the participant must meet at least one criterion for obesity and at least one criterion for sarcopenia, as defined below:
- Obesity:
- Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association) Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for women (World Health Organization)
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- Sarcopenia:
- Grip strength women: < 16 kg, men: < 27 kg in the dominant hand Gait speed < 0.8 m/s (men and women)
- Acceptable stages:
- STAGE I: No complications attributable to altered body composition and skeletal muscle functional parameters STAGE II: Presence of up to two complications attributable to altered body composition and skeletal muscle functional parameters (e.g. metabolic syndrome components, disabilities resulting from high fat mass and/or low muscle mass, cardiovascular and respiratory disease). Limitations apply (see exclusion criteria).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the STEM-META clinical protocol
- In order to understand the nature of this study it is expected that most participants will be able to speak, read, and understand English, or Spanish however, additional translations of the informed consent may be made available after study initiation to include additional languages for participants
- Study participant is willing and able to comply with all study requirements, according to the judgment of the Investigator.
- To be eligible for enrollment and for each treatment administration, the vital signs pre-dose, should be in the following ranges. If the vitals are outside of the range, will be reassessed 3 times at 10 minutes resting intervals.
- Heart rate >50 and <100 bpm Systolic pressure >100 and <170 mmHg Diastolic pressure >50 and <100 mmHg Blood oxygenation (by pulse-oximetry) >95%
Who cannot join
- Unmanaged/uncontrolled comorbidities (examples include high blood pressure, hyperglycemia, unstable angina, deep vein thrombosis, hepatic cirrhosis, peptic ulcers, complicated GERD, COPD, asthma etc.) as judged by the investigator.
- Type 1 Diabetes Mellitus, insulin-dependent Type 2 Diabetes mellitus, or hemoglobin A1C level >7.0%
- Severe obesity, or class III obesity (CDC criteria, BMI >40)
- Current diagnosis of major psychiatric disorders that may impact participation, as judged by the investigator.
- Conditions that interfere with gait balance or mobility, such as severe arthritis of lumbo-sacral area, hip or lower extremities if gait speed is used for inclusion criteria
- Conditions that interfere with ability to measure grip strength including hand arthritis, carpal tunnel syndrome and elbow tendinitis if hand grip criteria is used for inclusion
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- Study participant has current or past history of invasive malignancy (5 years) excluding non-melanoma skin cancer.
- Inflammatory conditions requiring regular use of oral or parenteral corticosteroids (Raynaud phenomenon, scleroderma, rheumatoid arthritis, LED etc.).
- Cushing's syndrome, Graves disease (hyperthyroidism), or other condition of hormone imbalance caused by genetic or auto-immune disorder. Exceptions include controlled hypothyroidism and polycystic ovarian syndrome.
- Severe cardiovascular disease (including New York Heart Association [NYHA] class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable defibrillator)
- Parkinson's disease, multiple sclerosis or other progressive neurological disorders
- Renal disease requiring dialysis, or known renal insufficiency (moderate or severe reduction in GFR≤30 ml/min/1.73 m2)
- Chest pain, severe shortness of breath, or occurrence of other safety concerns during the baseline functional tests
- Study participant is taking or has taken a prohibited medication as defined in Section 6.8.2 of the clinical protocol.
- Participant has had a change in medication to manage comorbid condition(s) (including diabetes, hypertension, asthma, and cardiovascular disease) within 1 month of the Screening visit.
- Weight loss (bariatric) surgery of any type including biliopancreatic diversion with duodenal switch, gastric bypass, sleeve gastrectomy, adjustable gastric banding, 1 year prior enrollment.
- Study participant has previously participated in this study or participant has previously been assigned to treatment in a study of the medication under investigation in this study.
- Study participant has been exposed to an investigational drug or device within 1 year, prior to the first dose of IMP, or is currently participating or planning to participate in another study of an investigational drug.
- Woman of Childbearing Potential (WOCBP) (defined as women with less than 12 months of amenorrhea).
- Unable to understand and/or perform the functional tests, as judged by the Investigator.
- Current physical/rehabilitation therapy (except for passive physical therapy)
- Substance abuse (including but not limited to alcohol, cannabis, narcotics, pain medication) as judged by the investigator.
- Smoking or vaping of products containing nicotine, tobacco or any other products, currently and in the past 1 year.
- Study participant is known positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) or human immunodeficiency virus-1/2 antibody (human immunovirus 1/2Ab)
- All participants will be encouraged to follow a healthy diet. Caloric restriction will not be pursued.
- Smoking of tobacco, marijuana or any other inhaled products (vaping) are prohibited during treatment and during the follow-up period
- There is no restriction on caffeine consumption
- Occasional alcohol consumption is acceptable, however the participants will be prohibited to consume alcohol 72 hours (3 days) prior medical and laboratory visits
- All participants in the trial (including placebo group) will be encouraged to increase daily physical activities. The participants can follow any preferred physical activity (walking, running, swimming, bicycle, treadmill, etc.), it can be evaluated by summed duration of a variety of activities, such as household work. The activity is measured by the sensors of the wearable activity tracker; thus, the nature of the activity is not critical.
- Activities that are conductive to falls and accidents are discouraged. Examples include horse riding, skiing, skydiving, scuba diving, mountain biking, bungee jumping, etc.
- Participant must be able to wear an activity tracker device daily, optional during sleep, and must be aware of the requirements to charge the tracker or transfer the data.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
National Institute of Clinical Research (NICR)
Garden Grove, California, 92844
Johnson Country Clinical Trials (JCCT)
Lenexa, Kansas, 66219
National Institute of Clinical Research (NICR)
Pomona, California, 91768
Tekton Research
Wichita, Kansas, 67218
About this study
Official title: Randomized Adaptive Study for Safety and Efficacy of Pluripotent Cell Secretome on Muscle Performance in Seniors With Sarcopenic Obesity
Placebo controlled study for safety and efficacy of IMM01-STEM on muscle performance in seniors with obesity and muscle weakness
Read the detailed description
This will be a two-phase, placebo-controlled, dose expansion study that begins with 4 parallel dosing groups and one placebo control group (phase IIa). The treatment period and follow up will last 16 weeks, then an interim adaptation will initiate the second phase of the study (IIb). The study will target safety parameters, body composition, and muscle strength and function. Additional metabolic, inflammatory, and muscle-adipose crosstalk markers will be monitored.
During screening, a wearable activity tracker will be assigned to each participant to establish a baseline of daily physical activity.
The treatment will be administered by intramuscular (IM) in a regimen of two injections per week with 2-3 days intervals between injections, for 4 weeks. The dosing groups vary by IMM01-STEM total protein and will be adjusted for identical volumes or equivalent saline volume for placebo. The proposed doses will be 0.5 mg administered twice per week; 1 mg once per week (alternating with a placebo given on the second visit of the week); 1 mg twice per week; and 2 mg once per week (also alternating with placebo).
Each participant will be evaluated at baseline, at the time of treatment administration during the treatment period, then monthly until the end of trial.
Interim analysis with the purpose of design adaptation will be performed after 10 participants from each group have completed treatment. This point will be marked by the date when the final participant to enroll has completed the final treatment on Week 12. This would occur about 16 weeks after the final participant starts treatment.
Statistical analysis will be performed on all recorded outcomes. All participants will continue to be followed-up per protocol for additional 8 weeks.
Post-adaptation, enrollment will be restarted in accordance with the new randomization rules in a 2-arm placebo-controlled study (IIb). The best responding dose will be chosen, or the most convenient treatment (lowest dose, less frequent administration) in the case that all treatment arms responded equally at interim analysis. An amended clinical protocol will be submitted prior initiation of the phase IIb study.
Study participants will sign a written Informed Consent Form (ICF) prior to any study-related procedures. Treatment must begin within 28 days of signing the ICF, during which participant screening and any necessary drug wash-out period must be completed. Screening assessments will be conducted as specified in the Schedule of Activities of the protocol, after which the study participants' eligibility will be determined based on the inclusion and exclusion criteria.
Site staff will administer study medication by IM injection in the gluteal area using a small-gauge needle at all scheduled treatment visits. If gluteal area is not feasible, alternatively i.m. injection can be administered in the quadriceps or deltoid area. After each administration of study medication, participants will be observed for 1 hour to monitor for acute injection-related reactions and other early onset treatment-related AEs.
- Conditions
- Muscle Performance, Sarcopenic Obesity
- Being tested
- IMM01-STEM, Placebo, IMM01-STEM alternating with placebo (saline)
- Keywords
- Muscle Performance, Sarcopenic Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM01-STEMBiological
IMM01-STEM is an allogeneic cell-free secretome product derived from partially differentiated human stem cells derived from a pluripotent embryonic stem cell line that was established from a single donor IVF discarded blastocyst. The cells are cultivated in bioreactors and the product of their secretion is collected, purified and concentrated to a standardized formulation. The secretome contains a mixture of molecules related to immunomodulation, growth, and extracellular matrix remodeling. This intervention is given 2mL twice a week.
PlaceboOther
Also called Saline
Saline. This intervention is given 2mL twice a week.
IMM01-STEM alternating with placebo (saline)Biological
This intervention consists of IMM01-STEM given once a week and placebo given one a week. IMM01-STEM is an allogeneic cell-free secretome product derived from partially differentiated human stem cells derived from a pluripotent embryonic stem cell line that was established from a single donor IVF discarded blastocyst. The cells are cultivated in bioreactors and the product of their secretion is collected, purified and concentrated to a standardized formulation. The secretome contains a mixture of molecules related to immunomodulation, growth, and extracellular matrix remodeling.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Placebo - 2 mL USP injectable saline, twice a week Receives: Other: Placebo |
| Group 2 | Experimental | 0.5 mg total protein in 2 mL final volume, twice a week Receives: Biological: IMM01-STEM |
| Group 3 | Experimental | 1 mg total protein in 2 mL final volume, once a week, alternating with placebo (saline) Receives: Biological: IMM01-STEM alternating with placebo (saline) |
| Group 4 | Experimental | 1 mg total protein in 2 mL final volume twice a week Receives: Biological: IMM01-STEM |
| Group 5 | Experimental | 2 mg total protein in 2 mL final volume, once a week, alternating with placebo (saline) Receives: Biological: IMM01-STEM alternating with placebo (saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Safety and tolerability of the IP will be measured by regular monitoring of study subjects' vital signs, blood and urine testing, symptom assessments, physical examinations and physical function testing to identify changes that may be related to the IP. Monitoring begins before treatment and continues for three months following the completion of treatment.
Measured: Time Frame: Day 0 to Day 28
Change over time in gait speed
Muscle strength and function efficacy information from this measure will be used to determine a dosing regimen for a confirmatory expanded study. This will be done using the The European Working Group on Sarcopenia in Older People (EWGSOP2) diagnostic criteria of sarcopenia gait speed.
Measured: Time Frame: Day 0 to Day 171
Secondary outcomes (3)
Change over time in grip strength
Muscle strength and function efficacy information from this measure will be considered for alternative efficacy outcome post interim adaptation. This will be done using the The European Working Group on Sarcopenia in Older People (EWGSOP2) diagnostic criteria of sarcopenia hand grip strength.
Measured: Time Frame: Day 0 to Day 171
Change over time in body composition using DXA
This outcome may be considered for alternative efficacy outcome post interim adaptation.
Measured: Time Frame: Day 0 to Day 171
Change over time in actigraphy parameters as reported by a wearable activity tracker
This purpose of this measurement is to evaluate additional outcomes that may be considered for alternative efficacy outcome post interim adaptation.
Measured: Time Frame: Day 0 to Day 171
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start19 Dec 2024
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle PerformanceStudies of the same condition, open and under way.
- 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
- Sequential
- Model description
- STEM-META is a placebo-controlled, randomized, dose expansion study that begins with 4 parallel dosing groups and one placebo control group (phase IIa). The treatment period and follow up will last 16 weeks, then an interim adaptation will initiate the second phase of the study (IIb). Treatment Groups Group 1 - Placebo - 2 mL USP injectable saline, twice a week Group 2 - 0.5 mg total protein in 2 mL final volume, twice a week Group 3 - 1 mg total protein in 2 mL final volume, once a week, alternating with saline Group 4 - 1 mg total protein in 2 mL final volume twice a week Group 5 - 2 mg total protein in 2 mL final volume, once a week, alternating with saline
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Immunis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Lane, PhD, Study director, Chief Science Officer at Immunis, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600581
- Sponsor's protocol ID
- STEM-META
- Status last verified
- Jan 2026
- First submitted
- 2 Aug 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Adaptive Study for Safety and Efficacy of Pluripotent Cell Secretome on Muscle Performance in Seniors With Sarcopenic Obesity
- ClinicalTrials.gov ID
- NCT06600581
- Acronym / sponsor ID
- STEM-META
- Conditions
- Muscle Performance, Sarcopenic Obesity
- Keywords
- Muscle Performance, Sarcopenic Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Immunis, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
Placebo controlled study for safety and efficacy of IMM01-STEM on muscle performance in seniors with obesity and muscle weakness
Detailed description
This will be a two-phase, placebo-controlled, dose expansion study that begins with 4 parallel dosing groups and one placebo control group (phase IIa). The treatment period and follow up will last 16 weeks, then an interim adaptation will initiate the second phase of the study (IIb). The study will target safety parameters, body composition, and muscle strength and function. Additional metabolic, inflammatory, and muscle-adipose crosstalk markers will be monitored.
During screening, a wearable activity tracker will be assigned to each participant to establish a baseline of daily physical activity.
The treatment will be administered by intramuscular (IM) in a regimen of two injections per week with 2-3 days intervals between injections, for 4 weeks. The dosing groups vary by IMM01-STEM total protein and will be adjusted for identical volumes or equivalent saline volume for placebo. The proposed doses will be 0.5 mg administered twice per week; 1 mg once per week (alternating with a placebo given on the second visit of the week); 1 mg twice per week; and 2 mg once per week (also alternating with placebo).
Each participant will be evaluated at baseline, at the time of treatment administration during the treatment period, then monthly until the end of trial.
Interim analysis with the purpose of design adaptation will be performed after 10 participants from each group have completed treatment. This point will be marked by the date when the final participant to enroll has completed the final treatment on Week 12. This would occur about 16 weeks after the final participant starts treatment.
Statistical analysis will be performed on all recorded outcomes. All participants will continue to be followed-up per protocol for additional 8 weeks.
Post-adaptation, enrollment will be restarted in accordance with the new randomization rules in a 2-arm placebo-controlled study (IIb). The best responding dose will be chosen, or the most convenient treatment (lowest dose, less frequent administration) in the case that all treatment arms responded equally at interim analysis. An amended clinical protocol will be submitted prior initiation of the phase IIb study.
Study participants will sign a written Informed Consent Form (ICF) prior to any study-related procedures. Treatment must begin within 28 days of signing the ICF, during which participant screening and any necessary drug wash-out period must be completed. Screening assessments will be conducted as specified in the Schedule of Activities of the protocol, after which the study participants' eligibility will be determined based on the inclusion and exclusion criteria.
Site staff will administer study medication by IM injection in the gluteal area using a small-gauge needle at all scheduled treatment visits. If gluteal area is not feasible, alternatively i.m. injection can be administered in the quadriceps or deltoid area. After each administration of study medication, participants will be observed for 1 hour to monitor for acute injection-related reactions and other early onset treatment-related AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- STEM-META is a placebo-controlled, randomized, dose expansion study that begins with 4 parallel dosing groups and one placebo control group (phase IIa). The treatment period and follow up will last 16 weeks, then an interim adaptation will initiate the second phase of the study (IIb). Treatment Groups Group 1 - Placebo - 2 mL USP injectable saline, twice a week Group 2 - 0.5 mg total protein in 2 mL final volume, twice a week Group 3 - 1 mg total protein in 2 mL final volume, once a week, alternating with saline Group 4 - 1 mg total protein in 2 mL final volume twice a week Group 5 - 2 mg total protein in 2 mL final volume, once a week, alternating with saline
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Other: PlaceboPlacebo - 2 mL USP injectable saline, twice a week |
| Group 2 | Experimental | Biological: IMM01-STEM0.5 mg total protein in 2 mL final volume, twice a week |
| Group 3 | Experimental | Biological: IMM01-STEM alternating with placebo (saline)1 mg total protein in 2 mL final volume, once a week, alternating with placebo (saline) |
| Group 4 | Experimental | Biological: IMM01-STEM1 mg total protein in 2 mL final volume twice a week |
| Group 5 | Experimental | Biological: IMM01-STEM alternating with placebo (saline)2 mg total protein in 2 mL final volume, once a week, alternating with placebo (saline) |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Sex: male or female
- Age 60 to 80 years of age at the time of signing the informed consent.
- Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria
- Disease characteristics: To be eligible, the participant must meet at least one criterion for obesity and at least one criterion for sarcopenia, as defined below:
- Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association) Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for women (World Health Organization)
Key exclusion criteria (31 listed)
- Unmanaged/uncontrolled comorbidities (examples include high blood pressure, hyperglycemia, unstable angina, deep vein thrombosis, hepatic cirrhosis, peptic ulcers, complicated GERD, COPD, asthma etc.) as judged by the investigator.
- Type 1 Diabetes Mellitus, insulin-dependent Type 2 Diabetes mellitus, or hemoglobin A1C level >7.0%
- Severe obesity, or class III obesity (CDC criteria, BMI >40)
- Current diagnosis of major psychiatric disorders that may impact participation, as judged by the investigator.
- Conditions that interfere with gait balance or mobility, such as severe arthritis of lumbo-sacral area, hip or lower extremities if gait speed is used for inclusion criteria
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 |
|---|---|---|
| IMM01-STEMIMM01-STEM is an allogeneic cell-free secretome product derived from partially differentiated human stem cells derived from a pluripotent embryonic stem cell line that was established from a single donor IVF discarded blastocyst. The cells are cultivated in bioreactors and the product of their secretion is collected, purified and concentrated to a standardized formulation. The secretome contains a mixture of molecules related to immunomodulation, growth, and extracellular matrix remodeling. This intervention is given 2mL twice a week. | Biological | Group 2, Group 4 |
| PlaceboAlso: SalineSaline. This intervention is given 2mL twice a week. | Other | Group 1 |
| IMM01-STEM alternating with placebo (saline)This intervention consists of IMM01-STEM given once a week and placebo given one a week. IMM01-STEM is an allogeneic cell-free secretome product derived from partially differentiated human stem cells derived from a pluripotent embryonic stem cell line that was established from a single donor IVF discarded blastocyst. The cells are cultivated in bioreactors and the product of their secretion is collected, purified and concentrated to a standardized formulation. The secretome contains a mixture of molecules related to immunomodulation, growth, and extracellular matrix remodeling. | Biological | Group 3, Group 5 |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Time Frame: Day 0 to Day 28
Safety and tolerability of the IP will be measured by regular monitoring of study subjects' vital signs, blood and urine testing, symptom assessments, physical examinations and physical function testing to identify changes that may be related to the IP. Monitoring begins before treatment and continues for three months following the completion of treatment.
Change over time in gait speed
Time frame: Time Frame: Day 0 to Day 171
Muscle strength and function efficacy information from this measure will be used to determine a dosing regimen for a confirmatory expanded study. This will be done using the The European Working Group on Sarcopenia in Older People (EWGSOP2) diagnostic criteria of sarcopenia gait speed.
3 secondary outcomes
Change over time in grip strength
Time frame: Time Frame: Day 0 to Day 171
Change over time in body composition using DXA
Time frame: Time Frame: Day 0 to Day 171
Change over time in actigraphy parameters as reported by a wearable activity tracker
Time frame: Time Frame: Day 0 to Day 171
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 29 Jan 2026.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data (IPD) available to other researchers.
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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. This study is not recruiting at the moment.
Tom Lane, PhD study director
Chief Science Officer at Immunis, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMM01-STEM in people with Muscle Performance and Sarcopenic Obesity, run by Immunis, Inc. at 4 sites in United States.
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 15 inclusion and 31 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: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Time Frame: Day 0 to Day 28). The study lists 2 primary outcomes in all. 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 29 Jan 2026.