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New treatment option for Obesity and Obesity-related Medical Conditions
Official title 2024 Tirzepatide-Bariatric Surgery
ClinicalTrials.gov ID: NCT06721507
What this study is testing
What is tirzepatide?
tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity and obesity-related medical conditions.
Also referred to as Mounjaro, Zepbound.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and...
- BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities
- have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
- enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)
You likely can't join if
- any contraindication to the use of tirzepatide (per package insert)
- Personal or family history of medullary thyroid carcinoma
- Patients with Multiple Endocrine Neoplasm syndrome type 2
- Hypersensitivity to tirzepatide
- History of pancreatitis
- Type 1 Diabetes
See the full eligibility criteria
- adults who have been enrolled in the multidisciplinary metabolic and bariatric surgery program at the UK HealthCare Weight Loss Surgery Clinic and are scheduled to receive laparoscopic or robotic sleeve gastrectomy, or...
- BMI greater than or equal to 40 kg/m2 with one or more obesity-related comorbidities
- have demonstrated abstinence from any form of nicotine use, confirmed by serum nicotine and metabolite testing
- enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)
- any contraindication to the use of tirzepatide (per package insert)
- Personal or family history of medullary thyroid carcinoma
- Patients with Multiple Endocrine Neoplasm syndrome type 2
- Hypersensitivity to tirzepatide
- History of pancreatitis
- Type 1 Diabetes
- patients with active, untreated or symptomatic cholelithiasis or jaundice
- consistent use of a GLP-1 or GLP-1/GIP receptor agonist, over the past 90 days
- diagnosed autoimmune disease
- current use of immunosuppressive agents or use within the past 30 days
- moderate or severe substance use disorder according to DSM-5 criteria
- uncontrolled significant psychiatric disorder as assessed by specialized bariatric psychologist
- female participant who is pregnant, breast-feeding, or intends to become pregnant with in 1 year following surgery
- a prisoner
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.