INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO TREATMENT FOR SARCOPENIC OBESITY (STEM-META-EAP)

March 5, 2026 updated by: Immunis, Inc.
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 Overview

Status

Temporarily not available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 14, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEM-META-EAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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