Phase 2 Obesity Trial, Recruiting NCT06802081 Sponsor: The Cleveland Clinic Condition: Obesity
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Phase 2 Obesity Trial, Recruiting

NCT06802081
Recruiting Phase 2

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 in a normal heart rhythm (called sinus rhythm) at the time of joining the trial
  • People aged 18 to 80 years old
  • People with a Body Mass Index (BMI) between 27 and 60
  • People who have been diagnosed with atrial fibrillation (an irregular heartbeat), confirmed by a heart tracing (ECG) or heart monitor, who experience symptoms from it, and whose atrial fibrillation is either occasional (paroxysmal) or ongoing (persistent)
  • People whose diabetes medications (including insulin, if taken) have not changed for at least 3 months before joining
  • People with Type 2 Diabetes who have an HbA1c (a blood sugar control measure) of 10% or below
  • People who are willing and able to self-administer the study medication, follow all study requirements, and sign a consent form

Who may not be able to join:

  • People who have had a procedure to treat atrial fibrillation (ablation) within the last 6 months
  • People who have a planned ablation procedure scheduled within 3 months after joining the trial
  • People who have significant heart valve disease and are scheduled for heart valve surgery or intervention within the next 12 months
  • People with severe, uncontrolled heart or lung disease
  • People whose heart failure is classified as a more serious stage (New York Heart Association Class III or IV) (confirm with trial site)
  • People whose heart pumping function is significantly reduced (left ventricular ejection fraction below 35%) at the time of screening
  • People who have been hospitalised in the past 6 months for a heart attack, unstable chest pain (angina), stroke, mini-stroke (transient ischemic attack), or heart surgery
  • People who have had a solid organ transplant (such as a kidney, liver, or heart transplant)
  • People with Type 1 diabetes or autoimmune diabetes
  • People with significantly reduced kidney function or who are on dialysis
  • People with advanced liver scarring (cirrhosis) with serious complications such as fluid build-up, brain problems related to liver disease, high blood pressure in the liver's blood vessels, or swollen veins in the oesophagus
  • People with a low haemoglobin (red blood cell) level below 9 g/dL (a measure of anaemia)
  • People currently participating in another clinical trial, or who have taken part in a drug or device trial within the last 3 months
  • People with significantly elevated liver enzyme levels (above 300 U/L)
  • People who report drinking, on average, more than 2 alcoholic drinks per day
  • People with an active cancer diagnosis (except certain minor skin cancers)
  • People whose life expectancy is less than 3 years due to other serious health conditions
  • People with significant mental health conditions, psychological disorders, or substance use disorders that would affect their suitability for the study
  • People with any other serious condition that, in the study doctor's judgment, puts them at undue risk from participating
  • People who plan to move away from the Northeast Ohio area within the next 12 months
  • People with a personal or family history of pancreatitis (inflamed pancreas), medullary thyroid cancer, or a condition called Multiple Endocrine Neoplasia Type 2 (MEN2)
  • People who are currently using, or have used within the last 6 months, certain diabetes or weight-related medications known as GLP-1, DPP4 inhibitors, or GIP/GLP-1 combination therapies (confirm with trial site for specific medication names)
  • People who have had a known allergic reaction to similar medications used in this trial
  • People with an allergy to medical-grade tape or adhesive
  • People who are pregnant, breastfeeding, or planning to become pregnant

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 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Leslie Cho, MD, The Cleveland Clinic

Phone: 216-559-7942

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 2
Registry
ClinicalTrials.gov
Start date
8 April 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

AFib burden

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: 28 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