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NCT06721507 · ClinicalTrials.gov registry record · Phase 4
2024 Tirzepatide-Bariatric Surgery
A Phase 4 study of Bariatric Surgery and Obesity and Obesity-related Medical Conditions, sponsored by Marlene Starr.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06721507: Recruiting Phase 4 study of Bariatric Surgery and Obesity and Obesity-related Medical Conditions, sponsored by Marlene Starr.
NCT06721507 is a Phase 4 study of Bariatric Surgery and Obesity and Obesity-related Medical Conditions that is actively recruiting participants, run by Marlene Starr. The registered enrollment target is 50 participants, below the 96-participant average among 15 other Bariatric Surgery trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06721507, a Phase 4 study of Bariatric Surgery and Obesity and Obesity-related Medical Conditions, is actively recruiting participants, sponsored by Marlene Starr.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Inflammatory marker will be measured by ELISA in blood samples drawn from patient.
Conditions Studied
Interventions
- BEHAVIORAL Standard of Care
- DRUG tirzepatide
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-03-27 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What NCT06721507 shows while recruiting
NCT06721507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 96-participant average among 15 other Bariatric Surgery trials with a reported enrollment target (48% lower).
The record links to 2 conditions, with Bariatric Surgery appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.
NCT06721507 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT06721507 about?
NCT06721507 is a clinical study titled "2024 Tirzepatide-Bariatric Surgery". 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 trea...
What is the current status of trial NCT06721507?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2025-03-27. Estimated completion is 2026-12-31.
What conditions does trial NCT06721507 study?
This clinical trial studies the following conditions: Bariatric Surgery, Obesity and Obesity-related Medical Conditions.
What interventions are being tested in trial NCT06721507?
The interventions under investigation include: Standard of Care (BEHAVIORAL), tirzepatide (DRUG).
Who is sponsoring clinical trial NCT06721507?
This trial is sponsored by Marlene Starr, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06721507 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06721507's enrollment target sits among peer trials
50 7th of 15 higher than 9 of 15 other Bariatric Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bariatric Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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