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New hope for sarcopenic obesity: expanded access program opens

NCT ID NCT06784297

Disease control Sponsor: Immunis, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused) This study
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This program offers expanded access to IMM01-STEM, an experimental treatment for sarcopenic obesity—a condition combining muscle loss and obesity. It is for patients who cannot join ongoing clinical trials due to location, eligibility, or other reasons. Participants receive weekly injections for four weeks. The goal is to provide potential benefit while more data is collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMM01-STEM (a stem cell-derived protein injection)
What this could lead to
If successful, this could provide a treatment option for people with sarcopenic obesity who cannot join standard clinical trials.
What could go wrong
This is an expanded access program, not a full clinical trial, so data on effectiveness and safety is limited. The treatment is still experimental.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Sex: male or post-menopausal female (as defined by the absence of a period for at least 12 consecutive months) 2. Race/nationality: all races and ethnicities accepted for which there are validated reference values for obesity and sarcopenia diagnostic criteria 3. Disease characteristics: to be eligible, the participant must meet one criterion for obesity and at least one criterion for sarcopenia, as defined below: Obesity: 1. Abdominal obesity defined by a waist circumference ≥ 40 inches (102 cm) for men, ≥ 35 inches (88 cm) for women (American Heart Association) 2. Abdominal obesity as a waist-to-hip ratio of at least 0.90 in men and 0.85 or more for 3. No obesity, normal BMI women (World Health Organization) Sarcopenia: i) 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 Exclusion Criteria: 1. 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. 2. Inability to sign an informed consent 3. Concomitant investigational drugs and treatments 4. Concomitant medication included in the table 1. 5. Current malignancy or recent malignancy in complete remission less than 3 years 6. BMI \< 20 7. Major surgical procedures in the past 30 days. 8. Cognitive impairment, Alzheimer disease, 9. Progressive autoimmune disorders including rheumatoid arthritis, muscular dystrophy, multiple sclerosis, systemic sclerosis, inclusion body myositis, idiopathic inflammatory myopathy, and similar conditions.

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Conditions

The condition(s) this trial relates to.

Obesity Sarcopenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity and obesity-related medical conditions Sarcopenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.