This study will compare measures of gut hormones, metabolites, subjective appetite and eating behaviors specifically during a designated test meal. The primary objective of this research is to test feasibility by assessing recruitment and rate of completion for this protocol.
Participants taking semaglutide or tirzepatide will complete two meal challenge sessions. During each session, participants will be video recorded while eating to assess eating behavior. An intravenous (IV) line will be placed to collect blood samples over a two-hour period following the start of the meal. Participants will also complete surveys throughout the session to assess subjective responses.
25-60 years old, non-smoker, does not have type-1 or type-2 diabetes. Inclusion Criteria: Adult males and females with a BMI of 30-45 kg/m2 (early group), or a BMI of 30-45 kg/m2 prior to weight loss achieved through medication (late group) Age, 25-60 years old Passing medical and physical screening, and analysis of blood and urine screening samples Anticipated to start or are already prescribed AOMs (semaglutide or tirzepatide) 6-months weight stable (early group) or 3 months weight stable at current weight (late group) Women of reproductive age must be using an effective form of contraception Exclusion Criteria: Diagnosed with type 1 or 2 diabetes Smoker Previous surgical treatment or device-based therapy for obesity Chronic or acute pancreatitis Clinically significant gastric emptying abnormality Uncontrolled hypertension or hypo/hyperthyroidism Cardiovascular event 3 months within screening Acute or chronic hepatitis Inability to tolerate beef, eggs, and cheese Women who are pregnant Women who are nursing
Protocol Number: 24-1896
More information available at ClinicalTrials.gov: NCT06856928