Not 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

Lead sponsor

Mayo Clinic

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Oncology

Eligibility highlights

•BMI ≥30•Female

Primary endpoints

•PWV between arms (Aim 1)•Protein expression between arms (Aim 2a)•Significantly enriched biological pathways and gene sets among DEPs (Aim 2b)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07769047

Org study ID25-012266

Secondary IDK23HL183845

Secondary IDNCI-2026-04536CTRP (Clinical Trial Reporting Program)

Timeline

Milestones

Study first posted2026-08-17actual

Last update posted2026-08-17actual

Study start2026-09-01estimated

Primary completion2031-07-30estimated

Study completion2035-07-30estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Oncology

Who can enroll

Minimum age46 Years

Maximum age55 Years

SexFemale

Healthy volunteersNot accepted

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

Endpoints (27)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in body weight between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in fat mass between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to 24 weeks

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in fasting glucose parameters between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in HbA1c between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints

Secondary/protocol endpoint

Change in blood pressure between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in total cholesterol between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in LDL-cholesterol between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in HDL-cholesterol between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in triglycerides between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in hs-CRP between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Other (unclassified)

16 endpoints

Primary/protocol endpoint/low confidence

Change in PWV between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in protein expression between arms (Aim 2a)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

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

Time frame:Up to 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Change in AIx between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in RHI between arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in PWV within arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in AIx within arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in RHI within arms (Aim 1)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in protein expression within arms (Aim 2a)

Time frame:Baseline to 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:At baseline

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:At 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:At baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Up to 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Up to 24 weeks

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Up to 24 weeks

descriptive

Other/protocol endpoint/low confidence

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

Time frame:Up to 24 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.