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NCT07808905
Evaluate the Efficacy and Safety of EN001 in Patients With Sarcopenia
Conditions: Sarcopenia
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 132
Sponsor: ENCell
Location: Samsung Medical Center Seoul
Summary
A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of EN001 in Patients with Sarcopenia
Eligibility Criteria
Inclusion Criteria:
* 1\) Male or Female aged 60 years or older at the time of providing written consent. : Female subjects must meet one of the following criteria for postmenopausal women\* :
* Postmenopausal women:
* Natural amenorrhea for 12 months
* At least 6 weeks after surgical menopause (bilateral oophorectomy)
* 2\) Individuals diagnosed with sarcopenia at the time of screening, based on the diagnostic criteria in Section 15.1 of the Asian Working Group for Sarcopenia(AWGS) 2019 guidlines, meeting (1) or (2) together with (3):
* (1) Handgrip Strength: \< 28kg(men), \
Source: ClinicalTrials.gov (NCT07808905). StuddyBuddy aggregates publicly available trial information.