Phase 4 Obesity Trial, Recruiting NCT06721507 Sponsor: Marlene Starr Condition: Obesity
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Phase 4 Obesity Trial, Recruiting

NCT06721507
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults who are already enrolled in the multidisciplinary weight loss surgery program at UK HealthCare Weight Loss Surgery Clinic and are scheduled to have sleeve gastrectomy or gastric bypass surgery (laparoscopic or robotic)
  • People with a BMI of 40 or higher who also have one or more health conditions related to obesity
  • People who have shown they are not currently using any form of nicotine, confirmed through a blood test
  • People who are enrolled in a specific tissue bank study called the ADORE Bariatric Tissue Bank (IRB #69767)

Who may not be able to join:

  • People who have any medical reason they cannot take the medication tirzepatide (confirm with trial site)
  • People with a personal or family history of a specific type of thyroid cancer called medullary thyroid carcinoma
  • People diagnosed with a hormonal condition called Multiple Endocrine Neoplasm syndrome type 2
  • People who have had an allergic reaction to tirzepatide
  • People with a history of pancreatitis (inflammation of the pancreas)
  • People with Type 1 Diabetes
  • People with active, untreated, or symptomatic gallstones or jaundice (yellowing of the skin or eyes)
  • People who have been regularly using a GLP-1 or GLP-1/GIP receptor agonist medication in the past 90 days (a type of diabetes or weight-loss medication — confirm with trial site)
  • People diagnosed with an autoimmune disease
  • People currently taking, or who have taken in the past 30 days, medications that suppress the immune system
  • People with a moderate or severe substance use disorder as defined by DSM-5 clinical guidelines
  • People with a significant, uncontrolled psychiatric condition, as assessed by a specialist bariatric psychologist
  • Female participants who are pregnant, breastfeeding, or planning to become pregnant within one year of surgery
  • People who are currently incarcerated

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 15 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Marlene Starr, PhD, University of Kentucky

Phone: 859-323-0471

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Marlene Starr
Registry
ClinicalTrials.gov
Start date
27 March 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in inflammatory markers c reactive protein (CRP); Change in inflammatory markers interleukin 6 (IL-6); Change in inflammatory markers tumor necrosis factor (TNF); change in inflammatory markers (leptin); change in inflammatory markers (adiponectin); change in inflammatory markers renin-angiotensin-aldosterone system (RAAS); RNA sequencing

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 15 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov