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

NCT06784297 | Unknown

• 1 other identifier: STEM-META-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcopenia; Obesity and Obesity-related Medical Conditions

Interventions

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 Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Immunis, Inc.: lead

MeSH Terms

Conditions

Sarcopenia; Obesity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03