Can a weekly shot help people who still struggle with weight after bariatric surgery?
NCT ID NCT07829198
First seen Sep 18, 2026 · Last updated Sep 18, 2026
Summary
Many people who have bariatric surgery do not lose as much weight as expected or regain it over time. This trial tests whether tirzepatide, a weekly injection that acts on two gut hormones, helps adults with obesity lose more weight after surgery. Participants receive either tirzepatide or a placebo for 52 weeks, and researchers measure changes in body weight, waist size, blood pressure, and metabolism. Neither participants nor staff know who gets which treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tirzepatide, a weekly injection that acts on two gut hormones to reduce appetite and food intake
- What this could lead to
- If it works, tirzepatide could become a standard option for people who still have obesity after bariatric surgery, helping them lose more weight and improve blood pressure and metabolism.
- What could go wrong
- This is a small Phase 3 trial of 70 people, so results may not apply to everyone. Tirzepatide can cause nausea, vomiting, and diarrhea, and weight often returns if the injections stop.
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.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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.
Inclusion Criteria: 1. Adults (male or female) aged ≥18 years. 2. History of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) performed ≥12 months before enrollment. 3. Current BMI ≥30 kg/m². 4. 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). 5. Absence of recent weight loss (defined as \<5% reduction in body weight over the 6 months prior to screening); participants may be weight stable (\<5% variation in body weight over the 6 months prior to screening) or have experienced weight gain. 6. In the investigator's opinion, well-motivated, capable, and willing to comply with study procedures. 7. For male participants: male participants with partners of childbearing potential should be willing to use reliable contraceptive methods throughout the study and for 5 half-lives of study drug plus 90 days, corresponding to 4 months after the last injection. 8. For female participants: a. Female participants not of childbearing potential may participate and include those who are: i. infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation), congenital anomaly such as Mullerian agenesis ii. postmenopausal, defined as either: * a woman at least 40 years of age with an intact uterus, not on hormone therapy, who has cessation of menses for at least 1 year without an alternative medical cause, AND a follicle-stimulating hormone ≥40mIU/mL; women in this category must test negative in pregnancy test prior to study entry * a woman 55 or older not on hormone therapy, who has had at least 12 months of spontaneous amenorrhea * a woman at least 55 years of age with a diagnosis of menopause prior to starting hormone replacement therapy b. Female participants of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: * test negative for pregnancy at Visit 1 based on a serum pregnancy test * if sexually active, agree to use 2 forms of effective contraception, where at least 1 form is highly effective, for the duration of the trial and for 30 days thereafter * not be breastfeeding 9. Provision of written informed consent prior to any study-specific procedures. Exclusion Criteria: 1. 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. 2. 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. 3. Have a planned surgical treatment, endoscopic and/or device-based therapy for obesity during the period of the study. 4. History of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c \>10%). 5. Type 2 diabetes currently treated with insulin or sulfonylureas. 6. Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility. 7. Have had a history of chronic or acute pancreatitis. 8. Have NYHA Functional Classification III or IV heart failure. 9. Have thyroid-stimulating hormone (TSH) outside of the reference range at screening visit. 10. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome). 11. Have a history of significant active or unstable Major Depressive Disorder or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years. 12. Have any lifetime history of a suicide attempt. 13. Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia (MEN) Syndrome type 2. 14. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site). 15. Participation in another clinical study with an investigational product during the last month. 16. Unwilling or unable to sign the informed consent form. 17. History of active malignancy within the past 5 years (except adequately treated non-melanoma skin cancer or in situ carcinoma of the cervix). 18. Known hypersensitivity or contraindication to tirzepatide or any of its excipients. 19. Have severe hepatic impairment (Child-Pugh class C). 20. Have severe renal impairment (eGFR \<30 mL/min/1.73 m² using CKD-EPI formula). 21. Are receiving or have received within 3 months prior to screening chronic (\>2 weeks or 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) or have evidence of a significant, active autoimmune abnormality (for example, lupus or rheumatoid arthritis) that has required (within the last 3 months) or is likely to require, in the opinion of the investigator, concurrent treatment with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular or inhaled preparations) in the next 12 months. 22. For female patients, pregnancy, breastfeeding, or planning pregnancy during the study period. 23. Any condition which, in the investigator's opinion, may jeopardize the subject's safety or compliance with the protocol (e.g., severe psychiatric illness, alcohol or substance abuse).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Unidade Local de Saúde de Entre Douro e Vouga
Santa Maria da Feira, Portugal
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Unidade Local de Saúde de Santo António
Porto, Portugal
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Unidade Local de Saúde de São João
Porto, Portugal
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