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:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT05088460
Eligibility Criteria:
Key Inclusion Criteria:
* Clinical diagnosis of familial partial lipodystrophy as defined in the protocol
* Fasting leptin level ≤20.0 ng/ml, as determined during the screening period
* Presence of significant metabolic abnormalities related to glucose and triglycerides (TGs) as defined in the protocol
* Stable body weight within the 3 months prior to screening (no gain or loss of \>5% current weight)
* Stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as Atkins, Paleo, Vegetarianism, Veganism)
* No clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol
Key Exclusion Criteria:
* Treatment with metreleptin within 3 months of the screening visit
* Patients with a diagnosis of generalized lipodystrophy
* Patients with a diagnosis of acquired lipodystrophy
* Pregnant or breastfeeding women
NOTE: Other protocol defined inclusion/exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05088460
Study Brief:
Protocol Section:
NCT05088460