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:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-26 @ 5:22 PM
NCT ID:
NCT05256706
Eligibility Criteria:
Inclusion Criteria:
* Male and female participants 40 years and older
* Diagnosis of type 2 diabetes (T2D) \[according to American Diabetes Association (ADA) guidelines\]
* Able to provide consent
* Eligible for (per drug label/guidelines) at least one of the following drug classes: sodium-glucose cotransporter 2 inhibitors (SGLT2i), proprotein convertase subtilisin/kexin type 9 (PCSK9i), glucagon-like peptide receptor agonists (GLP-1 RA) but not currently prescribed any of these classes of drugs, or only prescribed PCSK9i
Exclusion Criteria:
* Systemic Lupus Erythematous (SLE)
* Pregnancy
* Intolerance or contraindication for use of GLP-1 RA, SGLT2i, and PCSK9i
* History of, an active, or untreated malignancy, in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years prior to, or are receiving or planning to receive therapy for cancer, at screening
* Inability to understand English (currently, SomaSignal testing information, guides, educational materials, and reports are only available in English.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05256706
Study Brief:
Protocol Section:
NCT05256706