Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity a… (NCT06600581) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Safety and Efficacy of IMM01-STEM Against Placebo on Muscle Performance in Seniors With Obesity and Muscle Weakness
United States55 participantsStarted 2024-12-19
Plain-language summary
Placebo controlled study for safety and efficacy of IMM01-STEM on muscle performance in seniors with obesity and muscle weakness
Who can participate
Age range60 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Sex: male or female
* Age 60 to 80 years of age at the time of signing the informed consent.
* 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 at least 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 women (World Health Organization)
Sarcopenia:
Grip strength women: \< 16 kg, men: \< 27 kg in the dominant hand Gait speed \< 0.8 m/s (men and women)
Acceptable stages:
STAGE I: No complications attributable to altered body composition and skeletal muscle functional parameters STAGE II: Presence of up to two complications attributable to altered body composition and skeletal muscle functional parameters (e.g. metabolic syndrome components, disabilities resulting from high fat mass and/or low muscle mass, cardiovascular and respiratory disease). Limitations apply (see exclusion criteria).
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the STEM-META clinical protocol
* In order to understand the nature of thi…
What they're measuring
1
Incidence and severity of treatment-emergent adverse events (TEAEs)