NCT07769047Not yet recruitingPhase 4
Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
Breast Cancer Survivors With Obesity - Semaglutide's Impact on Preclinical Markers of Cardiovascular Disease
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
This phase IV trial studies whether adding semaglutide to structured lifestyle support improves heart and blood vessel health in postmenopausal obese breast cancer survivors (BCS) who are taking an aromatase inhibitor. In postmenopausal BCS who are taking an aromatase inhibitor, obesity raises the risk of heart and blood vessel problems. Semaglutide is a medicine approved by the United States Food and Drug Administration for weight loss and for lowering the risk of heart events in people with heart disease. The structured lifestyle support in this trial includes counseling on nutrition and physical activity which provides specific recommendations for individuals to follow.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 22 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Jul 2031
- Lead sponsor
- Mayo Clinic
- Diseases
- Obesity
- NCT number
- NCT07769047
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- From 1 Sept 2026 to the primary completion date, 30 Jul 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \> 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
Other illness
- 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
Lab values
- Impaired renal function \[glomerular filtration rate (GFR) ≤ 30 ml/min/1.73 m\^²\]
- Hemoglobin \< 11 mg/dL
Age
- 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)
Other
- Statin use
- Thyroid-stimulating hormone (TSH) ≥ 7 with low free thyroxine (T4)
Who the study is looking for
- 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
Age in the registry: 46 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Florida Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.