SarcopeniaSTEM-META-EAPNCT06784297
INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO TREATMENT FOR SARCOPENIC OBESITY
A study testing IMM01-STEM in people with Sarcopenia and Obesity and Obesity-related Medical Conditions, run by Immunis, Inc..
Trial summary
The expanded access is designed for patients requesting the treatment, and whose medical condition may benefit from treatment, but are unable to participate in any other IMM01-STEM clinical trial in their physician's opinion for reasons that include: (1) They do not meet enrollment criteria, or (2) They cannot perform… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Obesity and Obesity-related Medical Conditions
- What is being tested?
- IMM01-STEM
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Sex: male or post-menopausal female (as defined by the absence of a period for at least 12 consecutive months)
- 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 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
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- No obesity, normal BMI women (World Health Organization)
- Sarcopenia:
- Grip strength: < 16 kg (women), < 27 kg (men) in the dominant hand, or, ii) Gait speed < 0.8 m/s (men and women) iii) Clinical evidence of sarcopenia alternative to grips strength and gait speed measurements, as judged by the physician
Who cannot join
- Qualifying individuals by the current enrollment criteria that are in a 50-mile geographical radius of any IMM01-STEM clinical trial site or a potential clinical site.
- Inability to sign an informed consent
- Concomitant investigational drugs and treatments
- Concomitant medication included in the table 1.
- Current malignancy or recent malignancy in complete remission less than 3 years
- BMI < 20
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- Major surgical procedures in the past 30 days.
- Cognitive impairment, Alzheimer disease,
- Progressive autoimmune disorders including rheumatoid arthritis, muscular dystrophy, multiple sclerosis, systemic sclerosis, inclusion body myositis, idiopathic inflammatory myopathy, and similar conditions.
About this study
The expanded access is designed for patients requesting the treatment, and whose medical condition may benefit from treatment, but are unable to participate in any other IMM01-STEM clinical trial in their physician's opinion for reasons that include: (1) They do not meet enrollment criteria, or (2) They cannot perform the assessment of outcomes, or (3) The trial site is not geographically accessible.
- Being tested
- IMM01-STEM
- Medical subject headings
- Sarcopenia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM01-STEMBiological
The individuals receiving expanded access will receive a treatment identical to the most convenient regimen in the current clinical trial (STEM-META). The treatment will consist of one i.m. injection per week containing 2 mg of total protein in 2 mL, for a total of 4 weeks (4 injections). As more efficacy information accumulates, the treatment plan will be adjusted accordingly to maximize the potential benefit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Immunis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784297
- Sponsor's protocol ID
- STEM-META-EAP
- Acronym
- STEM-META-EAP
- Status last verified
- Mar 2026
- First submitted
- 14 Jan 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO TREATMENT FOR SARCOPENIC OBESITY
- ClinicalTrials.gov ID
- NCT06784297
- Acronym / sponsor ID
- STEM-META-EAP / STEM-META-EAP
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Immunis, Inc.Industry (pharma, biotech, devices)
- First posted
- 20 Jan 2025 (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 expanded access is designed for patients requesting the treatment, and whose medical condition may benefit from treatment, but are unable to participate in any other IMM01-STEM clinical trial in their physician's opinion for reasons that include: (1) They do not meet enrollment criteria, or (2) They cannot perform the assessment of outcomes, or (3) The trial site is not geographically accessible.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sex: male or post-menopausal female (as defined by the absence of a period for at least 12 consecutive months)
- 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 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
Key exclusion criteria (9 listed)
- Qualifying individuals by the current enrollment criteria that are in a 50-mile geographical radius of any IMM01-STEM clinical trial site or a potential clinical site.
- Inability to sign an informed consent
- Concomitant investigational drugs and treatments
- Concomitant medication included in the table 1.
- Current malignancy or recent malignancy in complete remission less than 3 years
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-STEMThe individuals receiving expanded access will receive a treatment identical to the most convenient regimen in the current clinical trial (STEM-META). The treatment will consist of one i.m. injection per week containing 2 mg of total protein in 2 mL, for a total of 4 weeks (4 injections). As more efficacy information accumulates, the treatment plan will be adjusted accordingly to maximize the potential benefit. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing IMM01-STEM in people with Sarcopenia and Obesity and Obesity-related Medical Conditions, run by Immunis, Inc..
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 9 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 6 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
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.
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 6 Mar 2026.