NCT07909889Not yet recruitingPhase 2
Semaglutide for Weight Management During Hormone Therapy for Early Breast Cancer
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.
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 27 Oct 2026
- Start date
- Mar 2027
- Primary completion date
- Mar 2029
- Lead sponsor
- Aarhus University Hospital
- Diseases
- Obesity
- NCT number
- NCT07909889
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 32
- From Mar 2027 to the primary completion date, Mar 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Lab values
- Type 1 or type 2 diabetes mellitus, or HbA1c of at least 48 mmol/mol.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Oncology, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.