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Phase 4 Obesity Trial, Recruiting
NCT07058155
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:
- People who are suitable candidates for general anaesthesia
- People aged between 18 and 70 years old at the time of giving consent
- People with a body mass index (BMI) between 35 and 70 at their first study visit
- People who meet the medical guidelines (ASMBS/IFSO 2022) for a type of weight-loss surgery called sleeve gastrectomy
- People whose health insurance covers metabolic (weight-loss) surgery
- People who are currently taking or have previously taken medication for obesity — this is permitted
- People who have been confirmed to have liver scarring (cirrhosis), either through a liver biopsy or approved non-invasive testing
- People who have a significant increase in blood pressure in the liver's main vein (portal hypertension), confirmed by specific measurements or imaging showing related changes in blood vessels or the stomach lining
- People who are willing and able to agree to participate and follow all study procedures
- Women who could become pregnant must have a negative pregnancy test at the start of the study and agree to use reliable contraception for 2 years
Who may not be able to join:
- People who have previously had weight-loss or metabolic surgery (unless a device was removed at least 3 months earlier)
- People who have had previous complex surgery involving the upper digestive tract
- People who have had a solid organ transplant (such as a kidney, heart, or liver)
- People with severe lung disease where lung function is measured at less than 50% of expected capacity
- People with significant heart or artery disease where a procedure to restore blood flow is planned within the next 12 months
- People with severe, uncontrolled heart or lung disease classified as ASA class IV or V (confirm with trial site)
- People whose heart pumping function is below 25%, or who have had a heart attack, unstable chest pain, stroke, heart surgery, or a coronary stent placed within the last 6 months
- People with a hiatal hernia larger than 7 cm, or a severe grade of inflammatory damage to the food pipe (LA grade C or D erosive oesophagitis)
- People with active Crohn's disease
- People with severe mental illness, dementia, active psychosis, a history of suicide attempts, or alcohol or substance misuse within the past 12 months
- People who are pregnant, breastfeeding, planning a pregnancy, or not using adequate contraception
- People who have been diagnosed with cancer in the past 12 months (except certain minor skin cancers)
- People whose treating doctor estimates their life expectancy to be less than 2 years
- People who have taken part in another experimental treatment study within the past 3 months
- People who have had a severe episode of pancreas inflammation (pancreatitis) within the past 90 days
- People who have a blood clot in the liver's main vein (portal vein thrombosis) at the time of screening
- People whose liver cirrhosis has led to serious complications such as moderate to large fluid build-up in the abdomen, confusion caused by liver failure, or who are on a waiting list for a liver transplant (note: small amounts of fluid or a past bleeding episode from veins in the food pipe may still be permitted — confirm with trial site)
- People with significantly abnormal liver blood test results or very low platelet counts within the past month (confirm specific values with trial site)
- People who have consumed more than 14 units of alcohol per week (for women) or more than 21 units per week (for men) at any point in the past 12 months
- People with significantly reduced kidney function or who are on dialysis, based on a blood test taken within the past month
- People living with AIDS
- People who are unable to understand the study or give informed consent
- People who plan to move more than 3 hours away from Cleveland within 6 months of joining
- People who have already taken part in this trial previously
- People who, in the treating doctor's judgement, have any condition that would put them at undue risk by participating
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.
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: Sobia Laique, MD, The Cleveland Clinic
Phone: +1 216 444 5022
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
Registry
ClinicalTrials.gov
Start date
17 December 2025
Est. completion
1 February 2029
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Change in SF-36 Physical Component Summary (PCS) Score From Baseline to 6 Months
Can't join this trial?
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.