Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT07072195
Eligibility Criteria:
Inclusion Criteria:
* Voluntary participation with written informed consent
* Male ≥ 65 years or postmenopausal female
* Diagnosed with sarcopenia:
* ASM \< 7.0 kg/m² (men) or \< 5.4 kg/m² (women)
* Plus low handgrip strength or SPPB ≤ 9
* MNA screening score ≥ 8
* Body weight ≥ 35 kg, BMI between 15-30 kg/m²
* Willing and able to follow exercise and nutrition guidance
Exclusion Criteria:
* Allergy to investigational drug
* History of GI bleeding, ulcers, or severe liver/kidney/heart disease
* QTc ≥ 450 ms with symptoms
* Severe COPD, uncontrolled diabetes or thyroid disease
* Diseases causing cachexia or muscle wasting (e.g., ALS, Parkinson's)
* Vitamin D deficiency (\<10 ng/mL), hemoglobin \<10 g/dL
* Severe psychiatric disorders or MMSE \< 21
* Inability to walk or recent fracture/surgery affecting mobility
* Use of prohibited medications or recent participation in other clinical trials
* Investigator deems the subject unsuitable for the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07072195
Study Brief:
Protocol Section:
NCT07072195