Early Phase 1 Obesity Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 65 years old who can understand instructions, follow the study procedures, and are willing to sign a consent form.
• People who are overweight or obese with a body mass index (a measure of weight relative to height) between 29.0 and 40.0.
• People who carry extra weight around the abdomen/middle of the body, confirmed through waist-to-hip measurements, a type of body scan (CT scan), or certain blood test results related to metabolism — the trial site can confirm which specific measurements apply.
• People who are able to eat all meals provided by the Mayo Clinical Research and Trials Unit for at least 3 days before the study begins.
• Women who are not pregnant or breastfeeding, and who test negative for pregnancy at the screening visit and again within 48 hours before the study drug is given.
• People with a fasting blood sugar level below 126 mg/dL (for those without diabetes).
• People whose blood counts meet minimum levels: haemoglobin of at least 11.0 for women and 12.0 for men, and platelets above 100,000 (confirm with trial site).
• People who have not taken part in another clinical trial involving an investigational drug within the past 12 weeks (or longer, depending on the drug used in the other trial).
• People whose total blood draws across studies do not exceed 450 mL within an 8-week period (confirm with trial site).

Who may not be able to join:

• People who have a history of heart disease, including conditions such as coronary artery disease, hardening of the heart valves, or peripheral artery disease (reduced blood flow to the limbs).
• People who have ever had a mini-stroke or transient ischemic attack (a brief episode of stroke-like symptoms).
• People with liver cirrhosis (serious scarring of the liver).
• People with significant kidney problems, as noted in their medical records.
• People whose blood pressure remains above 160/95 even while taking blood pressure medication.
• People who currently smoke.
• People who have been diagnosed with diabetes.
• People currently taking certain medications that can affect how the body processes fats, including statins, niacin, fibrates, thiazolidinediones, beta-blockers, corticosteroids or anabolic steroids (oral or injected), linezolid, dihydroergotamine, phenelzine, or daily phosphodiesterase inhibitors — the trial site or treating doctor can advise on whether a medication hold or doctor approval may allow participation in some cases.
• People with an allergy to lidocaine (a local anaesthetic).
• People with an allergy to indocyanine green (a dye used in medical imaging).

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