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NOT YET RECRUITING
NCT07829198
PHASE3

Efficacy of Tirzepatide for Weight Management in Patients With Suboptimal Weight Loss After Bariatric Surgery: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Sponsor: Universidade do Porto

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2027-01

Completion Date

2028-12

Last Updated

2026-09-18

Healthy Volunteers

No

Conditions

Interventions

DRUG

Tirzepatide

Dual 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.

DRUG

Placebo

Matching 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

Locations (3)

Unidade Local de Saúde de Santo António

Porto, Portugal

Unidade Local de Saúde de São João

Porto, Portugal

Unidade Local de Saúde de Entre Douro e Vouga

Santa Maria da Feira, Portugal