Exclusion Criteria
Characteristics that disqualify potential participants from a clinical trial, designed to protect patient safety and reduce confounding variables. Common exclusion criteria for peptide drug trials include pregnancy, severe organ dysfunction, known hypersensitivity, and use of conflicting medications.
Technical Context
Common exclusion criteria for peptide drug trials include: pregnancy or planned pregnancy (most peptide drugs are contraindicated), breastfeeding, severe renal impairment (eGFR <30 mL/min — affects peptide clearance), severe hepatic impairment, known hypersensitivity to the drug or class, history of pancreatitis (for GLP-1 RAs), personal/family history of medullary thyroid carcinoma or MEN2 (for GLP-1 RAs), type 1 diabetes (for type 2 diabetes trials), bariatric surgery within specified timeframe, recent use of competing therapies (washout required), psychiatric illness affecting consent capacity, and participation in another clinical trial. Exclusion criteria protect participant safety but reduce generalisability.