INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO... | NCT06784297

Studies
INTERMEDIATE-SIZE PATIENT POPULATIONS EXPANDED ACCESS TO TREATMENT FOR SARCOPENIC OBESITY

NCT06784297

Sponsor

Immunis, Inc.

Status

Temporarily not available

Last Update Posted

Mar 6, 2026Actual

Enrollment

Not provided

Phase

Not provided

Conditions

Sarcopenia
Obesity and Obesity-related Medical Conditions

Interventions

IMM01-STEM

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Temporarily not available

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jan 14, 2025

First Submission Date that Met QC Criteria

Jan 14, 2025

First Posted Date

Jan 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2026

Last Update Posted Date

Mar 6, 2026Actual

Description Module

Brief 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 the assessment of outcomes, or (3) The trial site is not geographically accessible.

Detailed Description

Not provided

Design Module

Study Type

Expanded Access

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Intermediate-type Population

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IMM01-STEM	Biological	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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
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:

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
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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009133	Muscular Atrophy
D020879	Neuromuscular Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D055948	Sarcopenia
D009765	Obesity