Phase 3 Obesity Trial, Recruiting

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

Who might be able to join this trial:

• People who are 45 years of age or older at the time of screening.
• People with a body mass index (BMI) of 27.0 or higher at the time of screening (this is a standard measure of body weight relative to height).
• People with a documented history of cardiovascular disease caused by plaque build-up in the arteries (known as ASCVD), including at least one of the following: a previous heart attack caused by a blocked artery; a previous stroke caused by a blocked artery (including strokes with some bleeding); or leg artery disease causing leg pain when walking, a low ankle-to-arm blood pressure ratio, a procedure to restore blood flow in leg arteries, or an amputation due to artery disease.

Who may not be able to join:

• People who have had a heart attack, been hospitalised for severe chest pain, had a procedure to open blocked arteries, had major heart or blood vessel surgery, had a stroke, or had a mini-stroke (TIA) in the 60 days before screening or between screening and the start of the trial.
• People with the most severe level of heart failure (classified as NYHA Class IV) at the time of screening, or who have been hospitalised for heart failure in the 60 days before screening or between screening and the start of the trial.
• People with Type 1 diabetes, or any form of diabetes other than Type 2 diabetes or a past history of gestational diabetes (diabetes during pregnancy).
• People with Type 2 diabetes (or those found to have blood sugar levels in the diabetic range during screening) who have any of the following: very poorly controlled blood sugar levels above a certain threshold at screening; a dangerous diabetic emergency (ketoacidosis or hyperosmolar coma) in the past 12 months; a severe low blood sugar episode in the past 6 months or a history of not being able to feel low blood sugar; or advanced diabetes-related eye disease, or current or planned treatment for diabetes-related eye complications.
• People who have used certain blood sugar-lowering medications — specifically GLP-1 receptor agonists, GIP agonists or antagonists, or amylin analogs — in the 90 days before the start of the trial, or who plan to use them during the trial (confirm specific medication names with the trial site).
• People with a history of long-term (chronic) pancreas inflammation, or a recent episode of acute pancreas inflammation in the 180 days before screening or between screening and the start of the trial.
• People who have a personal history, or a close family history (parent, sibling, or child), of a rare type of thyroid cancer called medullary thyroid carcinoma (MTC), or a related inherited condition called multiple endocrine neoplasia type 2 (MEN-2).
• People whose blood test at screening shows a calcitonin level (a marker related to thyroid health) at or above a certain level.
• People with active or long-term liver disease other than a specific type of fatty liver condition, or whose liver enzyme or bilirubin levels are significantly elevated on screening blood tests.
• People who have been diagnosed with cancer in the past 5 years before screening or between screening and the start of the trial — with some exceptions for certain early-stage or skin cancers that have been fully treated (confirm with trial site).
• People who are capable of becoming pregnant and are planning a pregnancy during the trial, or who are unwilling to use the contraception methods required by the trial protocol.

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