Weight-Loss drug shows promise for regain after gastric sleeve
NCT ID NCT07382180
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This completed study looked at how tirzepatide, a weight-loss drug, works in real-world settings for two groups: people who regained weight after gastric sleeve surgery, and those preparing for obesity surgery. Researchers tracked weight and metabolic changes over 6 months in 254 adults. The goal was to see if tirzepatide helps manage weight in these challenging situations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirzepatide
- What this could lead to
- If results are positive, this could support using tirzepatide as a standard option for managing weight regain after bariatric surgery or before surgery.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by patient selection and other factors. It does not prove long-term safety or effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
254 people
The number who actually took part.
- Started
-
Feb 2025
- Finished
-
Jan 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of adult patients with obesity managed within established bariatric and metabolic care pathways at participating referral centers. Participants are selected from individuals who initiate tirzepatide therapy as part of routine clinical practice, either for medical optimization prior to planned bariatric surgery or for the management of clinically significant weight regain following prior sleeve gastrectomy. All participants receive standard multidisciplinary care, including medical, nutritional, and metabolic evaluation, and are followed longitudinally through scheduled outpatient visits. The study population reflects a real-world clinical setting and includes patients with a broad range of obesity-related metabolic profiles, representative of routine bariatric practice.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
nclusion Criteria * Adult patients aged 18 years or older. * Diagnosis of obesity, defined according to standard clinical criteria, managed within a bariatric and metabolic care pathway. * Initiation of tirzepatide therapy at a starting dose of 5 mg as part of routine clinical practice. * Allocation to one of the following clinical cohorts: * Patients with prior sleeve gastrectomy and clinically significant weight regain, defined as a ≥25% increase in body weight relative to the postoperative nadir weight, with a minimum interval of 36 months from surgery; or * Patients with obesity undergoing preoperative medical optimization prior to planned bariatric surgery. * Availability of complete baseline clinical and anthropometric data at treatment initiation. * Planned clinical follow-up for at least 6 months after initiation of tirzepatide therapy. * Ability to provide written informed consent for the use of clinical data for research purposes, according to local regulations. Exclusion Criteria * Age younger than 18 years. * Prior bariatric procedures other than sleeve gastrectomy (for the weight regain cohort). * Current or previous treatment with tirzepatide before study enrollment. * Use of other anti-obesity pharmacological agents during the observation period. * Contraindications to tirzepatide therapy according to the approved product label. * Pregnancy or breastfeeding at the time of treatment initiation or during follow-up. * Presence of severe medical, psychiatric, or cognitive conditions that, in the investigator's judgment, could interfere with adherence to treatment or follow-up assessments. * Incomplete baseline data or anticipated inability to complete the planned 6-month follow-up.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Head of bariatric surgery
Naples, 80131, Italy
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Other studies related to the condition(s) this trial covers.
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