Inclusion Criteria
The specific characteristics that participants must have to be eligible for a clinical trial, such as age range, diagnosis, disease severity, and prior treatment history. For GLP-1 receptor agonist weight management trials, typical inclusion criteria include BMI thresholds and specific comorbidities.
Technical Context
Inclusion criteria define the target population and ensure enrolled participants can meaningfully contribute to the trial's objectives. For GLP-1 RA diabetes trials (example SUSTAIN programme): adults ≥18 years, type 2 diabetes diagnosis, HbA1c 7.0-10.5%, on stable background metformin for ≥30 days. For weight management trials (example STEP programme): adults ≥18 years, BMI ≥30 or ≥27 with at least one weight-related comorbidity, history of at least one self-reported unsuccessful dietary effort. Overly restrictive criteria improve internal validity (cleaner data) but reduce generalisability (may not reflect real-world patient populations). Recent FDA guidance encourages broadening inclusion criteria to improve demographic representation.