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Not yet taking people in United StatesPhase 4

Semaglutide plus lifestyle support for heart health in breast cancer survivors with obesity

Tests semaglutide with lifestyle counseling in postmenopausal breast cancer survivors with obesity.

Key facts

Who runs it
Mayo Clinic
Where
Jacksonville, United StatesSee the site
Trial code
Registry title
Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
Status
Not yet recruiting
Phase
Phase 4
People taking part
50 people, planned
Started
1 Sept 2026
Expected to end
30 Jul 2035
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Biospecimen Collection
  • Dual X-ray Absorptiometry
  • Functional Assessment
  • Lifestyle Counseling
  • Semaglutide
Record updated
17 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for postmenopausal women aged 46-55 with obesity who had breast cancer in the past five years and now take an aromatase inhibitor.

Age
46 to 55 years
Sex
Women only
Disease stage
Breast cancer stage 1, 2 or 3, diagnosed after menopause and within the past five years. BMI of 30 kg/m^2 or more.
Earlier treatment
Must be taking an aromatase inhibitor now. Cannot have had chemotherapy, radiation therapy or immunotherapy for breast cancer. No other anti-obesity medicine in the past 3 months.

Main reasons for not taking part

  • Heart or blood vessel disease such as ischemic heart disease, peripheral vascular disease or stroke
  • Type 1 or type 2 diabetes
  • Statin use, or a history of smoking
  • Early menopause, before age 46
  • Contraindications to GLP-1 receptor agonist therapy

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • > 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
  • 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
  • Impaired renal function [glomerular filtration rate (GFR) ≤ 30 ml/min/1.73 m\^²]
  • Hemoglobin < 11 mg/dL
  • 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)
  • Statin use
  • Thyroid-stimulating hormone (TSH) ≥ 7 with low free thyroxine (T4)

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 46 and 55 years old?

Where in United States

  • Mayo Clinic in FloridaJacksonville, United StatesContact: General Clinical Studies UnitNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Arm I (LM)Existing treatment, for comparison

    Patients receive recommendations for a structured lifestyle intervention over 24 weeks consisting of the following: 1) a low-calorie diet based on their Harris-Benedict predicted resting energy expenditure, reduced by 500 kcal/day; (2) a physical activity goal of ≥ 10,000 steps/day; (3) ≥ 150 minutes per week of moderate-intensity aerobic exercise with resistance training; and (4) limited liquid calorie intake (e.g., sodas, juices, alcohol). Additionally, patients undergo blood sample collection, vascular function testing, and DEXA on study.

    Treatment: Biospecimen Collection, Dual X-ray Absorptiometry, Functional Assessment, and Lifestyle Counseling

  • Arm II (LM+Sema)Treatment being tested

    Patients receive recommendations for a structured lifestyle intervention over 24 weeks consisting of the following: 1) a low-calorie diet based on their Harris-Benedict predicted resting energy expenditure, reduced by 500 kcal/day; (2) a physical activity goal of ≥ 10,000 steps/day; (3) ≥ 150 minutes per week of moderate-intensity aerobic exercise with resistance training; and (4) limited liquid calorie intake (e.g., sodas, juices, alcohol). Patients also receive semaglutide SC QW for up to 24 weeks in the absence of unacceptable toxicity. Additionally, patients undergo blood sample collection, vascular function testing, and DEXA on study.

    Treatment: Biospecimen Collection, Dual X-ray Absorptiometry, Functional Assessment, Lifestyle Counseling, and Semaglutide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Breast Cancer Survivors With Obesity - Semaglutide's Impact on Preclinical Markers of Cardiovascular Disease
Plain-language title
Semaglutide plus lifestyle support for heart health in breast cancer survivors with obesityGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07769047, who can take part
Record updated
17 August 2026