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

NCTNCT07769047Other id25-012266Other idK23HL183845Other idNCI-2026-04536

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Not yet recruiting
Phase: Phase 4
Enrollment: 50 participants (estimated)
Sponsor: Mayo Clinic · Other
Design: Randomized · Single masking
Countries: 1 country
United States
Start: 1 Sept 2026 (estimated)
Primary completion: 30 Jul 2031 (estimated)
Completion: 30 Jul 2035 (estimated)
First posted: 17 Aug 2026
Last update posted: 17 Aug 2026
Conditions: Anatomic Stage I Breast Cancer AJCC v8 · Anatomic Stage II Breast Cancer AJCC v8 · Anatomic Stage III Breast Cancer AJCC v8

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202620282030203220342036

Ph 4
Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
NCT07769047
est. 1 Sept 2026 to est. 30 Jul 2035

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Biospecimen CollectionProcedure
Dual X-ray AbsorptiometryProcedure
Functional AssessmentOther
Lifestyle CounselingBehavioral
SemaglutideDrug

Arms2

Active comparator
Arm I (LM)
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.
Experimental
Arm II (LM+Sema)
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.

Primary outcomes3

Outcomes the sponsor listed as primary.

Change in PWV between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the change in pulse wave velocity (PWV) between arms from baseline to 24 weeks.
Change in protein expression between arms (Aim 2a)
Time frame · Baseline to 24 weeks
Registry description
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.
Significantly enriched biological pathways and gene sets among DEPs (Aim 2b)
Time frame · Up to 24 weeks
Registry description
Will identify biological pathways and gene sets significantly enriched among the differentially expressed proteins (DEPs) between arms.

Secondary outcomes(20)

Change in AIx between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in augmentation index (AIx) from baseline to 24 weeks between arms.
Change in RHI between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in reactive hyperemic index (RHI)from baseline to 24 weeks between arms.
Change in PWV within arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the change in pulse wave velocity (PWV) from baseline to 24 weeks within each arm.
Change in AIx within arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the change in AIx from baseline to 24 weeks within each arm.
Change in RHI within arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the change in RHI from baseline to 24 weeks within each arm.
Change in body weight between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in body weight from baseline to 24 weeks between arms.
Change in fat mass between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in total fat mass and visceral fat mass from baseline to 24 weeks between arms.
Change in waist and hip circumference between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in waist and hip circumference from baseline to 24 weeks between arms.
Change in blood pressure between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in systolic and/or diastolic blood pressure from baseline to 24 weeks between arms.
Change in total cholesterol between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in total cholesterol from baseline to 24 weeks between arms.
Change in LDL-cholesterol between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in LDL-cholesterol from baseline to 24 weeks between arms.
Change in HDL-cholesterol between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in HDL-cholesterol from baseline to 24 weeks between arms.
Change in triglycerides between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in triglycerides from baseline to 24 weeks between arms.
Change in fasting glucose parameters between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in fasting glucose from baseline to 24 weeks between arms.
Change in HbA1c between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in HbA1c from baseline to 24 weeks between arms.
Change in hs-CRP between arms (Aim 1)
Time frame · Baseline to 24 weeks
Registry description
Will assess the difference in change in high-sensitivity (hs) C-reactive protein (CRP) (hs-CRP) from baseline to 24 weeks between arms.
Change in protein expression within arms (Aim 2a)
Time frame · Baseline to 24 weeks
Registry description
Will assess the change in protein expression from baseline to 24 weeks within each arm.
Difference in protein expression between arms at baseline (Aim 2a)
Time frame · At baseline
Registry description
Will assess the difference in protein expression at baseline between arms.
Difference in protein expression between arms at 24 weeks (Aim 2a)
Time frame · At 24 weeks
Registry description
Will assess the difference in protein expression at 24 weeks between arms.
Overlap of change in protein expression within arms (Aim 2a)
Time frame · At baseline and 24 weeks
Registry description
Will assess overlap between the two arms in change in protein expression within each arm at baseline and at 24 weeks.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 46 Years up to 55 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

PepBank is a research reference. Talk to a doctor before you use any peptide.