Could a diabetes drug before bariatric surgery supercharge weight loss?
NCT ID NCT07622992
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study will compare three approaches before gastric bypass surgery for severe obesity: taking the medication tirzepatide for 60 days, following a ketogenic diet for 4 weeks, or receiving standard care. The goal is to see which method leads to the most weight loss one year after surgery. The trial will also track safety and improvements in related health issues like diabetes and high blood pressure.
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 successful, this could show that a short course of tirzepatide before surgery leads to greater weight loss and better control of obesity-related conditions like diabetes and high blood pressure.
- What could go wrong
- This is a small, early-stage study with only 96 participants, so results may not apply to everyone. The benefits of tirzepatide may not persist long-term, and the drug can cause side effects like nausea or vomiting.
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
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About 96 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 2029
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.
Who is studied
Patients between 18 to 65 years, with Body Mass Index (BMI) between 40 and 55 kg/m² at screening visit. The patients must be eligible for bariatric surgery according to current international guidelines (IFSO 2022) with documented failure of conservative weight loss attempts. Patients enrolled need to have at least one obesity-related comorbidity and the ability to understand study procedures and provide written consent.
- Ages
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18 to 65 years
- 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: * Age 18 to 65 years at enrollment * Body Mass Index (BMI) between 40 and 55 kg/m² at screening visit * Appropriate candidates for bariatric surgery according to current international guidelines (IFSO 2022) with documented failure of conservative weight loss attempts * Presence of at least one obesity-related comorbidity: Type 2 Diabetes Mellitus (HbA1c at least 6.5%, fasting plasma glucose at least 126 mg/dL, 2-hour OGTT glucose at least 200 mg/dL, or use of antidiabetic medications); Hypertension (systolic BP at least 140 mmHg or diastolic BP at least 90 mmHg, or use of antihypertensive medications); Dyslipidemia (total cholesterol at least 200 mg/dL, LDL-C at least 130 mg/dL, HDL-C less than 40 mg/dL for men or less than 50 mg/dL for women, triglycerides at least 150 mg/dL, or use of lipid-lowering medications); Obstructive Sleep Apnea Syndrome (AHI at least 15 events/hour or AHI 5-14 with symptoms requiring treatment) * Ability to understand study procedures and provide written informed consent * Demonstrated ability and willingness to adhere to study protocol requirements including preoperative interventions and postoperative follow-up visits * No use of GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists within 12 months prior to enrollment Exclusion Criteria: * History of any prior bariatric procedure or major upper gastrointestinal surgery that could confound outcomes or increase surgical risk * Severe uncontrolled psychiatric disorders including active psychosis, severe depression with suicidal ideation, active substance abuse, or eating disorders (other than binge eating disorder) that could impair protocol adherence or informed consent capacity * Current pregnancy, lactation, or planning pregnancy within 18 months of enrollment (women of childbearing potential must use effective contraception throughout study period) * Contraindications to tirzepatide for patients potentially randomized to Arm A: personal or family history of medullary thyroid carcinoma; Multiple Endocrine Neoplasia syndrome type 2 (MEN 2); history of pancreatitis; severe gastrointestinal disease (inflammatory bowel disease, gastroparesis); known hypersensitivity to tirzepatide or excipients * Contraindications to ketogenic diet for patients potentially randomized to Arm B: chronic kidney disease (eGFR less than 30 mL/min/1.73m²); severe hepatic insufficiency (Child-Pugh C); active gallbladder disease; history of kidney stones; porphyria; carnitine deficiency or other metabolic disorders * Current or recent malignancy (within 5 years) at any stage * Severe cardiopulmonary disease including recent myocardial infarction (less than 6 months), unstable angina, heart failure (NYHA class III-IV), severe pulmonary hypertension, or other conditions representing absolute contraindications to general anesthesia * Systemic infection requiring treatment at time of enrollment * Inability or unwillingness to attend required follow-up visits, language barriers preventing adequate communication, or any condition that would compromise protocol compliance
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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 places running it
1 site. 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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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University Federico II of Naples
Naples, Italy, 80131, Italy
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