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Trial · Interventional

RecruitingPhase 4Registry data

2024 Tirzepatide-Bariatric Surgery

NCTNCT06721507 (opens ClinicalTrials.gov in a new tab)Other id97933
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
50 participants (estimated)
Sponsor
Marlene Starr · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
27 Mar 2025
Primary completion
31 Dec 2026 (estimated)
Completion
31 Dec 2026 (estimated)
First posted
6 Dec 2024
Last update posted
14 May 2026
Conditions
Obesity and Obesity-related Medical Conditions · Bariatric Surgery

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 4

    2024 Tirzepatide-Bariatric Surgery

    NCT06721507

    27 Mar 2025 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • tirzepatideDrug
  • Standard of CareBehavioral

Arms2

  • Experimental

    Standard of Care plus Drug

    Participant receives drug for 3 months prior to surgery

  • Active comparator

    Standard of Care Alone

Primary outcomes7

Outcomes the sponsor listed as primary.

  1. Change in inflammatory markers c reactive protein (CRP)

    Time frame · Baseline and 3 months post-drug

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  2. Change in inflammatory markers interleukin 6 (IL-6)

    Time frame · Baseline and 3 months post-drug

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  3. Change in inflammatory markers tumor necrosis factor (TNF)

    Time frame · Baseline and 3 months post-drug

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  4. change in inflammatory markers (leptin)

    Time frame · Baseline and 3 months post-drug

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  5. change in inflammatory markers (adiponectin)

    Time frame · Baseline and 3 months post-drug

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  6. change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)

    Time frame · Baseline and 3 months post-drug

    Registry description

    Inflammatory markers will be measured by ELISA in blood samples drawn from patient.

  7. RNA sequencing

    Time frame · at time of surgery

    Registry description

    Bulk RNA sequencing analyses will be performed on tissue samples of fat and liver collected at the time of surgery

Secondary outcomes(16)

  1. Change in weight

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    patient weight will be measured

  2. 30-day surgical complications

    Time frame · 1-,6-, and 12-months post surgery

    Registry description

    Surgical complications will be assessed as standard of care and data evaluated for this study

  3. change in inflammatory markers c reactive protein (CRP)

    Time frame · 1-, 6-, and 12-months post surgery

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  4. change in inflammatory markers interleukin 6 (IL-6)

    Time frame · 1-, 6-, and 12-months post surgery

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  5. change in inflammatory markers tumor necrosis factor (TNF)

    Time frame · 1-, 6-, and 12-months post surgery

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  6. change in inflammatory markers (leptin)

    Time frame · 1-, 6-, and 12-months post surgery

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  7. change in inflammatory markers (adiponectin)

    Time frame · 1-, 6-, and 12-months post surgery

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  8. change in inflammatory markers renin-angiotensin-aldosterone system (RAAS)

    Time frame · 1-, 6-, and 12-months post surgery

    Registry description

    Inflammatory marker will be measured by ELISA in blood samples drawn from patient.

  9. change in blood pressure

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    blood pressure per standard method in clinic

  10. Change in Hemoglobin A1c

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    HbA1c will be measured by clinic lab

  11. change in blood glucose

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    blood glucose will me measured in clinic lab

  12. change in cholesterol

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    cholesterol measured in clinic lab

  13. change in high-density lipoprotein (HDL)

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    high-density lipoprotein (HDL) measured in clinic lab

  14. change in low-density lipoprotein (LDL)

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    low-density lipoprotein measured by clinic lab

  15. change in triglycerides

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    triglycerides measured in clinic lab

  16. change in insulin

    Time frame · Baseline, 3 months post-drug, 1-, 6-, and 12-months post surgery

    Registry description

    insulin measured in clinic lab

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

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Indexing hint: Clinical trial · 2026

Preoperative Glucagon-like Peptide-1 Therapy in Bariatric Surgery Patients With Morbid Obesity (PreMO): Rationale and Study Design for a Randomized Controlled Trial.

Jain et al. 2026The Journal of surgical research

PMID 41643256PMC13159554DOI 10.1016/j.jss.2026.01.004PUB-41643256

Free to read · publisher termsCC BY-NC-ND
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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, or gastric bypass surgery * 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) 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 * 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

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