Incretin Microdosing for Cardiometabolic Health in People With HIV

Exclusion Criteria

• •Weight greater than or equal to 400 pounds \[due to dual X-ray absorptiometry (DXA) machine limitations\] or unexplained weight change greater than or equal to 5% in the 12 weeks prior to entry
• •Diagnosis of or on treatment for diabetes mellitus (stable metformin dosing for pre-diabetes not excluded)
• •Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period
• •Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period
• •Active eating disorder
• •Use of human growth hormone, tesamorelin or anabolic steroids \<12 weeks prior to entry, unless on a stable dose for \>24 weeks prior to entry, or plans to start any of these medications while on study
• •Active, severe delayed gastric emptying
• •Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study
• •Known retinopathy
• •Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
• •Untreated, poorly controlled or previously undiagnosed thyroid disease
• •Chronic pancreatitis
• •Known allergy/sensitivity to Glucagon-Like Peptide-1 Receptor Agonist (GLP-1RA)
• •Poorly controlled or previously undiagnosed thyroid disease, defined as thyroid-stimulating hormone (TSH) \<0.5 or \>10 milli-international units per liter (mIU/L) at screening
• •Active drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
• •Pregnancy, nursing or plans for either during the study period
• •Use of planned use of any immunomodulatory therapy HIV vaccine, investigational therapy or tumor necrosis factor (TNF-α) therapy during the study period
• •Current serious illness requiring systemic treatment and/or hospitalization, in the opinion of site investigator