Semaglutide for weight loss in women with early breast cancer taking hormone therapy
Tests semaglutide in women with obesity and early hormone-receptor-positive breast cancer.
Plain-language title generated from the registry record
Registry title: Semaglutide for Weight Management During Hormone Therapy for Early Breast Cancer
Key facts
- Where
- Aarhus N, DenmarkSee the site
- Phase
- Phase 2
Where in Denmark
- Department of Oncology, Aarhus University HospitalAarhus N, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aarhus University Hospital
- Trial code
- NCT07909889
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: Female diagnosed with estrogen receptor-positive early breast cancer (stage I-III); 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; Body mass index of at least 30 kg/m² at screening; Eastern Cooperative Oncology Group performance status 0-1; Age 18 years or older; Able to provide oral and written informed consent in Danish.
Exclusion: Ongoing treatment with semaglutide or another GLP-1 receptor agonist, or previous use of any pharmacological weight-reducing agent within the last 6 months; 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; Current participation in another interventional drug trial; Type 1 or type 2 diabetes mellitus, or HbA1c of at least 48 mmol/mol; Self-reported alcohol intake exceeding 14 units per week, or severe substance abuse; Known pregnancy at screening; Women of childbearing potential who are unable or unwilling to use contraception; Currently breastfeeding; 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; Any circumstance that, in the investigator's judgment, would interfere with trial conduct, participant safety or the validity of trial outcomes.