Phase 2 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 have a confirmed diagnosis of HIV-1 (a specific type of HIV).
• People who have been on HIV treatment (antiretroviral therapy) for at least 24 weeks before joining, with no changes to that treatment in the past 12 weeks and no planned changes during the study.
• People whose HIV viral load (the amount of HIV detected in the blood) is below 200 copies/mL at the screening visit.
• People with a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher if they also have at least one health condition related to weight (confirm with trial site for examples).
• People taking anti-inflammatory, blood pressure, cholesterol, or blood sugar medications, provided the dose has not changed in the past 12 weeks and there are no plans to increase the dose during the study.
• People who are willing and able to sign a written consent form and take part in all required study activities.

Who may not be able to join:

• People who weigh 400 pounds or more (due to limits of the scanning equipment used in the study), or who have had an unexplained weight change of 5% or more in the past 12 weeks.
• People who have been diagnosed with diabetes or are being treated for it (note: people on a stable dose of metformin for pre-diabetes are not automatically excluded — confirm with trial site).
• People who are currently using or planning to use medications for weight loss, or any medications likely to cause significant weight changes, during the study.
• People who are planning to start a new, structured intensive exercise program or a specialised diet (such as a ketogenic or very low carbohydrate diet) during the study.
• People with an active eating disorder.
• People who have used human growth hormone, tesamorelin, or anabolic steroids in the 12 weeks before joining, unless they have been on a stable dose for more than 24 weeks, or who plan to start any of these during the study.
• People with active, severe problems with stomach emptying (a condition where the stomach takes too long to empty food).
• People who have had bariatric (weight loss) surgery or major stomach surgery in the past, or who plan to have weight loss surgery during the study.
• People with a known diagnosis of retinopathy (a condition affecting the eyes).
• People with a personal history, or a parent or sibling with a history, of medullary thyroid cancer or a condition called multiple endocrine neoplasia type 2.
• People with untreated, poorly controlled, or previously undiagnosed thyroid disease, including those whose thyroid hormone levels fall outside a specific range at screening (confirm with trial site for exact values).
• People with chronic pancreatitis (long-term inflammation of the pancreas).
• People with a known allergy or sensitivity to a class of medications called GLP-1 receptor agonists.
• People whose current drug or alcohol use, in the opinion of the study doctor, would make it difficult to follow the study requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
• People who are using or planning to use immunomodulatory therapy, an HIV vaccine, an investigational (experimental) therapy, or TNF-α therapy during the study.
• People who have a serious active illness that requires ongoing treatment or hospitalisation, in the opinion of the study doctor.

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