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
Study ID
NCT07829198
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    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.
  • Placebo — DRUG
    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

Study Details

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 Dates

First listed
Sep 18, 2026
Start date
Jan 31, 2027
Status verified
Sep 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Participants will receive tirzepatide once weekly by subcutaneous injection, self-administered at home. Treatment will start at 2.5 mg once weekly, with up-titration in 2.5 mg increments every 4 weeks (5 mg, 7.5 mg, 10 mg, 12.5 mg, up to 15 mg), according to tolerability, up to the maximum tolerated dose or 15 mg once weekly. Treatment will continue for a total of 52 weeks.
  • Placebo Comparator: Placebo
    Participants will receive matching placebo (identical prefilled syringe) once weekly by subcutaneous injection, self-administered at home, following the same up-titration schedule and visit schedule as the tirzepatide arm, for a total of 52 weeks.

Primary Outcome Measure

Percentage Change in Body Weight from Baseline to Week 52 [ Time Frame: Baseline (Week 0) to Week 52 ]

Central Contacts

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