Many people who have bariatric (weight-loss) surgery do not lose as much weight as expected, or they regain weight over time. This study will test whether a medicine called tirzepatide can help these patients lose more weight and improve their overall health.
Participants who had bariatric surgery at least one year ago and still have obesity with insufficient weight loss will be randomly assigned, like a coin flip, to receive either tirzepatide or a placebo (an inactive injection that looks the same). Neither participants nor study staff will know who is receiving which treatment.
Participants will inject the study medicine or placebo once a week for 52 weeks, starting at a low dose that is gradually increased. During the study, researchers will measure body weight, waist size, blood pressure, and blood tests related to metabolism and inflammation. Participants will also answer questionnaires about their quality of life.
The main goal is to find out whether tirzepatide leads to greater weight loss than placebo after one year of treatment.
Adults (male or female) aged ≥18 years.
History of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) performed ≥12 months before enrollment.
Current BMI ≥30 kg/m².
Evidence of suboptimal weight loss, defined as percentage total weight loss (%TWL) since surgery of less than 25% (defined as the percentage of weight loss comparing current body weight with body weight before surgery).
Use of a GLP-1 receptor agonist (GLP-1 RA) or any other GLP-1-based therapy at present or within the past 6 months.
Prescription of a GLP-1 RA or other GLP-1-based therapy within the past 12 months that could not be initiated or maintained due to drug supply shortages.
Have a planned surgical treatment, endoscopic and/or device-based therapy for obesity during the period of the study.
History of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >10%).
Parallel
Tirzepatide
DrugDual GIP/GLP-1 receptor agonist supplied as a prefilled syringe (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg) for subcutaneous injection, manufactured by Eli Lilly and Company. Self-administered once weekly by the participant in the abdomen, thigh, or upper arm, with rotating injection sites. Dose up-titrated every 4 weeks in 2.5 mg increments, up to a maximum of 15 mg or the maximum tolerated dose, for a total treatment duration of 52 weeks.
Placebo
DrugMatching placebo, supplied as a prefilled syringe identical in appearance to the tirzepatide syringe, manufactured by Eli Lilly and Company. Self-administered once weekly by subcutaneous injection, following the same up-titration schedule, injection sites, and visit schedule as the tirzepatide arm, for a total of 52 weeks
Percentage Change in Body Weight from Baseline to Week 52
To assess the effect of tirzepatide versus placebo on the percentage change in body weight relative to baseline at week 52
Change in Body Weight
Change in body weight (kg) from baseline.
Change in Body Mass Index (BMI)
Change in BMI, calculated as body weight in kilograms divided by the square of height in meters
Change in Waist Circumference
Change in waist circumference (cm)
Change in Blood Pressure
Change in systolic and diastolic blood pressure (mmHg), measured in triplicate after rest.
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Universidade do Porto
Lead sponsor
Eli Lilly and Company
Collaborator
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