Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors

Korábbi kezelés

• \> 5% change in weight during the 3 months prior to screening and/or weight fluctuation of ≥ 20 pounds within the past 6 months (self-report)
• Other anti-obesity medication used within the past 3 months
• Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed \> 1 year before screening)
• Past or intended endoscopic and/or device-based therapy or removal within the last six months
• Current or recent (within 3 months) use of medications that may cause weight gain, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers
• Current or recent use (within 3 months) of systemic glucocorticoid therapy for over 2 weeks
• Contraindications to glucagon-like peptide 1 (GLP-1) receptor agonist therapy
• Currently enrolled in another clinical study involving an investigational product or participated in one and received treatment (active or placebo) in the last 30 days

Más betegség

• History of established cardiovascular disease, including coronary atherosclerosis, ischemic heart disease, peripheral vascular disease, or stroke
• 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk \> 7.5%
• History of smoking
• History of type 1 or type 2 diabetes
• Use of chemotherapy, radiation therapy, or immunotherapy for breast cancer treatment
• Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease

Laborértékek

• Impaired renal function \[glomerular filtration rate (GFR) ≤ 30 ml/min/1.73 m\^²\]
• Hemoglobin \< 11 mg/dL

Életkor

• Early menopause (menopause occurring before age 46)
• Family history of premature cardiovascular disease in a first-degree relative (before 45 years old in male relatives and before 55 years old in female relatives)

Egyéb

• Statin use
• Thyroid-stimulating hormone (TSH) ≥ 7 with low free thyroxine (T4)

• Breast cancer diagnosed after menopause (menopause defined as the natural/spontaneous cessation of menses for at least 12 months)
• Breast cancer (BC) diagnosed within the past five years
• BC stage 1, 2, or 3
• Aged 46-55 years
• Body mass index (BMI) ≥ 30 kg/m\^²
• Current use of an aromatase inhibitor
• Ability to participate in all portions of the study, including willingness to self-inject