40
Participants
Start Date
September 16, 2025
Primary Completion Date
September 18, 2027
Study Completion Date
September 18, 2027
Tirzepatide
"Tirzepatide will be administered with a starting dose of 2.5 mg weekly, subcutaneously injected. The dose will increase by 2.5 mg every 4 weeks until reaching 15 mg.~Participants will be asked to follow lifestyle interventions:~* Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day~* Physical activity: a goal of 10,000 steps or more per day~* Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week~* Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.)."
Placebo
"A placebo for Tirzepatide will be administered with a starting dose of 2.5 mg weekly, subcutaneously injected. The dose will increase by 2.5 mg every 4 weeks until reaching 15 mg.~Participants will be asked to follow lifestyle interventions:~* Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day~* Physical activity: a goal of 10,000 steps or more per day~* Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week~* Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.)."
Mayo Clinic in Florida, Jacksonville
Lead Sponsor
Mayo Clinic
OTHER