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NCT Number: NCT07769047

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

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.

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Key information

Conditions

Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8

Age range

46 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location contact

General Clinical Studies Unit

CONTACT

904-953-2255

Maria Daniela Hurtado Andrade, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • > 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)
  • Early menopause (menopause occurring before age 46)
  • History of established cardiovascular disease, including coronary atherosclerosis, ischemic heart disease, peripheral vascular disease, or stroke
  • Statin use
  • 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk > 7.5%
  • History of smoking
  • History of type 1 or type 2 diabetes
  • 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)
  • Use of chemotherapy, radiation therapy, or immunotherapy for breast cancer treatment
  • Impaired renal function [glomerular filtration rate (GFR) ≤ 30 ml/min/1.73 m^²]
  • Thyroid-stimulating hormone (TSH) ≥ 7 with low free thyroxine (T4)
  • Hemoglobin < 11 mg/dL
  • Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease
  • 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

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Dual X-ray Absorptiometry

Procedure

Undergo DEXA

Other names: BMD scan, bone mineral density scan, DEXA, DEXA (Bone Density), DEXA Scan, dual energy x-ray absorptiometric scan, Dual Energy X-ray Absorptiometry, Dual X-Ray Absorptometry, DXA, DXA SCAN

functional assessment

Other

Undergo vascular function testing

Lifestyle Counseling

Behavioral

Receive structured lifestyle intervention recommendations

semaglutide

Drug

Given SC

Other names: Ozempic, Rybelsus, Wegovy

Primary outcomes

  1. Change in PWV between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the change in pulse wave velocity (PWV) between arms from baseline to 24 weeks.

  2. Change in protein expression between arms (Aim 2a)

    Time frame: Baseline to 24 weeks

    Will assess the change in protein expression from baseline to 24 weeks between arms. The raw protein concentrations for all samples will be reported in Normalized Protein eXpression (NPX) values, as obtained from the OLINK platform . A log2 scale transformation will be applied to the NPX values to stabilize variance across samples and allow data to be comparable.

  3. Significantly enriched biological pathways and gene sets among DEPs (Aim 2b)

    Time frame: Up to 24 weeks

    Will identify biological pathways and gene sets significantly enriched among the differentially expressed proteins (DEPs) between arms.

Secondary outcomes

  1. Change in AIx between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in augmentation index (AIx) from baseline to 24 weeks between arms.

  2. Change in RHI between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in reactive hyperemic index (RHI)from baseline to 24 weeks between arms.

  3. Change in PWV within arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the change in pulse wave velocity (PWV) from baseline to 24 weeks within each arm.

  4. Change in AIx within arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the change in AIx from baseline to 24 weeks within each arm.

  5. Change in RHI within arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the change in RHI from baseline to 24 weeks within each arm.

  6. Change in body weight between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in body weight from baseline to 24 weeks between arms.

  7. Change in fat mass between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in total fat mass and visceral fat mass from baseline to 24 weeks between arms.

  8. Change in waist and hip circumference between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in waist and hip circumference from baseline to 24 weeks between arms.

  9. Change in blood pressure between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in systolic and/or diastolic blood pressure from baseline to 24 weeks between arms.

  10. Change in total cholesterol between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in total cholesterol from baseline to 24 weeks between arms.

  11. Change in LDL-cholesterol between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in LDL-cholesterol from baseline to 24 weeks between arms.

  12. Change in HDL-cholesterol between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in HDL-cholesterol from baseline to 24 weeks between arms.

  13. Change in triglycerides between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in triglycerides from baseline to 24 weeks between arms.

  14. Change in fasting glucose parameters between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in fasting glucose from baseline to 24 weeks between arms.

  15. Change in HbA1c between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in HbA1c from baseline to 24 weeks between arms.

  16. Change in hs-CRP between arms (Aim 1)

    Time frame: Baseline to 24 weeks

    Will assess the difference in change in high-sensitivity (hs) C-reactive protein (CRP) (hs-CRP) from baseline to 24 weeks between arms.

  17. Change in protein expression within arms (Aim 2a)

    Time frame: Baseline to 24 weeks

    Will assess the change in protein expression from baseline to 24 weeks within each arm.

  18. Difference in protein expression between arms at baseline (Aim 2a)

    Time frame: At baseline

    Will assess the difference in protein expression at baseline between arms.

  19. Difference in protein expression between arms at 24 weeks (Aim 2a)

    Time frame: At 24 weeks

    Will assess the difference in protein expression at 24 weeks between arms.

  20. Overlap of change in protein expression within arms (Aim 2a)

    Time frame: At baseline and 24 weeks

    Will assess overlap between the two arms in change in protein expression within each arm at baseline and at 24 weeks.

  21. Key hub proteins as central regulators in semaglutide-mediated effects (Aim 2b)

    Time frame: Up to 24 weeks

    Will identify key hub proteins that may serve as central regulators in semaglutide-mediated effects.

  22. Network connectivity between DEPs and known molecular pathways (Aim 2b)

    Time frame: Up to 24 weeks

    Will assess network connectivity between DEPs and known molecular pathways relevant to metabolic and vascular function.

  23. Overlap of DEPs and established cardiovascular risk biomarkers (Aim 2b)

    Time frame: Up to 24 weeks

    Will evaluate the overlap between DEPs and established cardiovascular risk biomarkers.

Other outcomes

  1. Examine functional significance of semaglutide-induced DEPs through enrichment analysis (Aim 2b)

    Time frame: Up to 24 weeks

    Will use enrichment analysis to assess semaglutide-induced DEP profiles for correlation with functional categories (e.g., inflammatory response, metabolic function, vascular remodeling, atherogenesis).

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

General Clinical Studies Unit

CONTACT

904-953-2255

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Breast Cancer Survivors With Obesity - Semaglutide's Impact on Preclinical Markers of Cardiovascular Disease

Important dates

Study start
2026
Primary completion
2031
Study completion
2035
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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