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NCT07909889

PHASE2

Semaglutide for Weight Management During Hormone Therapy for Early Breast Cancer

Sponsor: Aarhus University Hospital

View on ClinicalTrials.gov

Summary

This study will assess whether women with obesity and early estrogen receptor-positive breast cancer can complete 26 weeks of semaglutide treatment while continuing their prescribed hormone therapy for breast cancer. The researchers expect that semaglutide can be given alongside hormone therapy with good treatment adherence. The study will also examine side effects, weight changes, body composition, metabolic health and quality of life. Thirty-two women will be randomly assigned to start semaglutide immediately or after a 26-week waiting period. Both groups will continue usual breast cancer care and receive written advice about diet and physical activity. Semaglutide will be self-injected under the skin once a week for 26 weeks, with the dose increased gradually according to tolerability. Participants will attend visits for weight and body measurements, blood tests, side-effect assessments and questionnaires. Follow-up will continue for 26 weeks after the treatment period. Total follow-up from randomization will be 52 weeks for the immediate-start group and 78 weeks for the delayed-start group. Some participants will also be invited to interviews about their experience of treatment.

Official title: Weight Loss Intervention With Semaglutide in Patients With Estrogen Receptor-positive Breast Cancer (WISPER): A Phase II, Randomized, Open-label, Single-center, Delayed-start Feasibility Trial of Glucagon-like Peptide-1 Receptor Agonist Therapy During Adjuvant Endocrine Therapy.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-03

Completion Date

2029-09

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Breast Cancer (Early Breast Cancer)Obesity

Interventions

DRUG

Semaglutide (Wegovy®)

Semaglutide is self-administered by subcutaneous injection once weekly for 26 weeks. Doses are 0.25 mg during treatment weeks 1-4, 0.5 mg during weeks 5-8, 1.0 mg during weeks 9-12, 1.7 mg during weeks 13-16, and a target maintenance dose of 2.4 mg during weeks 17-26. Dose escalation may be delayed or the dose temporarily reduced for significant gastrointestinal symptoms. Treatment starts at randomization in the immediate-start arm and at trial week 26 in the delayed-start arm.

Inclusion Criteria: 1. Female diagnosed with estrogen receptor-positive early breast cancer (stage I-III). 2. Currently receiving, or planning to initiate, adjuvant endocrine therapy for early estrogen receptor-positive breast cancer, with at least 78 weeks of planned endocrine therapy remaining at randomization. 3. Body mass index of at least 30 kg/m² at screening. 4. Eastern Cooperative Oncology Group performance status 0-1. 5. Age 18 years or older. 6. Able to provide oral and written informed consent in Danish. Exclusion Criteria: 1. Ongoing treatment with semaglutide or another GLP-1 receptor agonist, or previous use of any pharmacological weight-reducing agent within the last 6 months. 2. Type 1 or type 2 diabetes mellitus, or HbA1c of at least 48 mmol/mol. 3. Self-reported alcohol intake exceeding 14 units per week, or severe substance abuse. 4. Known pregnancy at screening. 5. Women of childbearing potential who are unable or unwilling to use contraception. 6. Significant somatic disease, defined as any of the following: * End-stage renal failure with estimated glomerular filtration rate below 15 mL/min/1.73 m². * Alanine or aspartate aminotransferase above twice the upper limit of normal. * History of acute or chronic pancreatitis. * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2. * New York Heart Association class IV heart failure, unstable angina pectoris, or myocardial infarction within the previous 6 months. * Uncontrolled hypertension, defined as systolic blood pressure above 180 mmHg or diastolic blood pressure above 100 mmHg. 7. Currently breastfeeding. 8. Women of childbearing potential who are unable or unwilling to use an effective contraceptive method during semaglutide treatment and for at least 2 months after the last dose. 9. Current participation in another interventional drug trial. 10. Any circumstance that, in the investigator's judgment, would interfere with trial conduct, participant safety or the validity of trial outcomes.

Locations (2)

Department of Oncology, Aarhus University Hospital

Aarhus N, Denmark