2024 Tirzepatide-Bariatric Surgery

Marlene Starr

Status and phase: Enrolling; Phase 4

Conditions: Bariatric Surgery; Obesity and Obesity-related Medical Conditions

Treatments: Behavioral: Standard of Care; Drug: tirzepatide

Study type: Interventional

Funder types: Other

Identifiers

NCT06721507

97933

Details and patient eligibility

About

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.

The major objectives are:

1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery.
2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery.

Participants will:

Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months.

Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug.

Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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
• BMI greater than or equal to 45 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
• have expressed preference and are deemed a suitable candidate for laparoscopic or robotic vertical sleeve gastrectomy
• enrollment in the ADORE Bariatric Tissue Bank (IRB #69767)

Exclusion criteria

• 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
• current use of a GLP-1 or GLP-1/GIP receptor agonist, or use within past 90 days
• a history of prior metabolic and bariatric surgery
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Standard of Care plus Drug

Experimental group

Description:

Participant receives drug for 3 months prior to surgery

Treatment:

Drug: tirzepatide

Standard of Care Alone

Active Comparator group

Treatment:

Behavioral: Standard of Care