WISPER

Not 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.

Lead sponsor

Aarhus University Hospital

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight, Oncology

Eligibility highlights

•BMI ≥30•Female

Primary endpoint

•Completion of the 26-week semaglutide treatment phase meeting all composite

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 IDNCT07909889

Org study IDSBSHWISPER

Timeline

Milestones

Study first posted2026-11-02actual

Last update posted2026-11-02actual

Study start2027-03estimated (month precision)

Primary completion2029-03estimated (month precision)

Study completion2029-09estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightOncology

Who can enroll

Minimum age18 Years

SexFemale

Healthy volunteersNot accepted

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.

Endpoints (79)

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)

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Other clinical outcomes

Weight & body composition

17 endpoints

Secondary/protocol endpoint

Participants achieving at least 5% weight loss at trial week 26

Time frame:From randomization to trial week 26 in both arms.

threshold achievement, improvement

Secondary/protocol endpoint

Percentage change in body weight from randomization to trial week 12

Time frame:Randomization baseline and trial week 12 in both arms.

percent change from baseline, improvement

Secondary/protocol endpoint

Change in fat mass after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Secondary/protocol endpoint

Change in fat mass percentage after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Longitudinal change in waist circumference

Time frame:At treatment start, 12 and 26 weeks of treatment, and 12 and 26 weeks after treatment: trial weeks 0, 12, 26, 38, 52 in Arm A and 26, 38, 52, 64, 78 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Longitudinal change in waist-to-hip ratio

Time frame:At treatment start, 12 and 26 weeks of treatment, and 12 and 26 weeks after treatment: trial weeks 0, 12, 26, 38, 52 in Arm A and 26, 38, 52, 64, 78 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Longitudinal change in fat mass

Time frame:At treatment start, 12 and 26 weeks of treatment, and 12 and 26 weeks after treatment: trial weeks 0, 12, 26, 38, 52 in Arm A and 26, 38, 52, 64, 78 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Longitudinal change in fat mass percentage

Time frame:At treatment start, 12 and 26 weeks of treatment, and 12 and 26 weeks after treatment: trial weeks 0, 12, 26, 38, 52 in Arm A and 26, 38, 52, 64, 78 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Participants achieving at least 10% weight loss after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

threshold achievement, improvement

Other/protocol endpoint

Percentage change in body weight from randomization to trial weeks 26 and 52

Time frame:Randomization baseline and trial weeks 26 and 52 in both arms.

percent change from baseline, improvement

Other/protocol endpoint

Change in body weight during post-treatment observation

Time frame:Trial weeks 26-52 in Arm A and trial weeks 52-78 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in waist-to-hip ratio after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in waist circumference after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in body mass index after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Participants achieving at least 15% weight loss after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

threshold achievement, improvement

Other/protocol endpoint

Association between semaglutide exposure and percentage weight change

Time frame:Exposure during 26 weeks of treatment and weight at treatment start and completion: trial weeks 0-26 in Arm A and 26-52 in Arm B.

descriptive

Other/protocol endpoint

To characterize changes in circulating inflammatory and immune-related biomarkers, adipokines, and adipose-associated metabolic biomarkers during GLP-1RA therapy and subsequent follow-up in participants receiving adjuvant endocrine therapy, using stored

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

descriptive

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in fasting plasma glucose after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in HbA1c after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Change in total cholesterol after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in resting pulse rate after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in LDL cholesterol after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in HDL cholesterol after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in triglycerides after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in C-reactive protein after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in resting systolic blood pressure after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint

Change in resting diastolic blood pressure after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Patient-reported symptomatic adverse events

Time frame:At protocol-specified assessments from treatment start to end of follow-up: trial weeks 0-52 in Arm A and 26-78 in Arm B.

descriptive

Secondary/protocol endpoint

Change in EORTC QLQ-C30 Global Health Status and Quality of Life score

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Safety / tolerability / PK

7 endpoints

Secondary/protocol endpoint

Adverse events during semaglutide treatment and post-treatment follow-up

Time frame:From the first semaglutide dose to end of follow-up: trial weeks 0-52 in Arm A and 26-78 in Arm B.

descriptive

Secondary/protocol endpoint

Serious adverse events

Time frame:From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.

descriptive

Secondary/protocol endpoint

Suspected unexpected serious adverse reactions

Time frame:From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.

descriptive

Secondary/protocol endpoint

Adverse events of special interest

Time frame:From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.

descriptive

Other/protocol endpoint

Apparent clearance of semaglutide

Time frame:Samples at trial weeks 12, 26, 38 and 52 in Arm A and trial weeks 26, 38, 52, 64 and 78 in Arm B.

concentration, descriptive

Other/protocol endpoint

Apparent volume of distribution of semaglutide

Time frame:Samples at trial weeks 12, 26, 38 and 52 in Arm A and trial weeks 26, 38, 52, 64 and 78 in Arm B.

descriptive

Other/protocol endpoint

Association between semaglutide exposure and adverse event count

Time frame:Adverse events recorded during the assigned 26-week treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.

descriptive

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Completion of the 26-week semaglutide treatment phase meeting all composite feasibility criteria

Time frame:At completion of 26 weeks of semaglutide treatment: trial week 26 in Arm A and trial week 52 in Arm B.

descriptive

Other/protocol endpoint

Participant retention

Time frame:At trial week 52 in Arm A and trial week 78 in Arm B.

descriptive

Other (unclassified)

41 endpoints

Secondary/protocol endpoint/low confidence

Semaglutide dose interruptions

Time frame:During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.

descriptive

Secondary/protocol endpoint/low confidence

Semaglutide dose reductions

Time frame:During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.

descriptive

Secondary/protocol endpoint/low confidence

Permanent discontinuation of semaglutide

Time frame:During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.

descriptive

Secondary/protocol endpoint/low confidence

Time to permanent discontinuation of semaglutide

Time frame:During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.

time to event, event

Secondary/protocol endpoint/low confidence

Permanent discontinuation of adjuvant endocrine therapy

Time frame:From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.

descriptive

Secondary/protocol endpoint/low confidence

Completion of the semaglutide treatment phase

Time frame:At trial week 26 in Arm A and trial week 52 in Arm B.

descriptive

Secondary/protocol endpoint/low confidence

Participant-reported acceptability of semaglutide treatment

Time frame:After treatment completion, within trial weeks 26-52 in Arm A and 52-78 in Arm B.

descriptive

Secondary/protocol endpoint/low confidence

Change in fat-free mass after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in fat-free mass percentage after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in skeletal muscle mass after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in EORTC QLQ-BR45 Body Image score

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Longitudinal change in hip circumference

Time frame:At treatment start, 12 and 26 weeks of treatment, and 12 and 26 weeks after treatment: trial weeks 0, 12, 26, 38, 52 in Arm A and 26, 38, 52, 64, 78 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Longitudinal change in fat-free mass

Time frame:At treatment start, 12 and 26 weeks of treatment, and 12 and 26 weeks after treatment: trial weeks 0, 12, 26, 38, 52 in Arm A and 26, 38, 52, 64, 78 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Longitudinal change in fat-free mass percentage

Time frame:At treatment start, 12 and 26 weeks of treatment, and 12 and 26 weeks after treatment: trial weeks 0, 12, 26, 38, 52 in Arm A and 26, 38, 52, 64, 78 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Longitudinal change in skeletal muscle mass

Time frame:At treatment start, 12 and 26 weeks of treatment, and 12 and 26 weeks after treatment: trial weeks 0, 12, 26, 38, 52 in Arm A and 26, 38, 52, 64, 78 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Recruitment proportion

Time frame:Throughout the recruitment period, approximately 12 months.

threshold achievement, improvement

Other/protocol endpoint/low confidence

Consent proportion

Time frame:Throughout the recruitment period, approximately 12 months.

threshold achievement, improvement

Other/protocol endpoint/low confidence

Change in hip circumference after 26 weeks of treatment

Time frame:From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Model-predicted average steady-state semaglutide concentration

Time frame:PK samples at trial weeks 12, 26, 38 and 52 in Arm A and weeks 26, 38, 52, 64 and 78 in Arm B; model prediction for a 168-hour steady-state dosing interval.

concentration, descriptive

Other/protocol endpoint/low confidence

Semaglutide exposure by concomitant endocrine therapy class

Time frame:Endocrine therapy and semaglutide PK data collected during the 26-week treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.

descriptive

Other/protocol endpoint/low confidence

Plasma tamoxifen concentrations during concomitant semaglutide treatment

Time frame:At 12 and 26 weeks after semaglutide initiation: trial weeks 12 and 26 in Arm A and weeks 38 and 52 in Arm B.

concentration, descriptive

Other/protocol endpoint/low confidence

Plasma endoxifen concentrations during concomitant semaglutide treatment

Time frame:At 12 and 26 weeks after semaglutide initiation: trial weeks 12 and 26 in Arm A and weeks 38 and 52 in Arm B.

concentration, descriptive

Other/protocol endpoint/low confidence

Plasma 4-hydroxytamoxifen concentrations during concomitant semaglutide treatment

Time frame:At 12 and 26 weeks after semaglutide initiation: trial weeks 12 and 26 in Arm A and weeks 38 and 52 in Arm B.

concentration, descriptive

Other/protocol endpoint/low confidence

Plasma letrozole concentrations during concomitant semaglutide treatment

Time frame:At 12 and 26 weeks after semaglutide initiation: trial weeks 12 and 26 in Arm A and weeks 38 and 52 in Arm B.

concentration, descriptive

Other/protocol endpoint/low confidence

Association between semaglutide exposure and temporary treatment interruptions

Time frame:During the assigned 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.

descriptive

Other/protocol endpoint/low confidence

Semaglutide exposure by permanent treatment discontinuation status

Time frame:Permanent discontinuation assessed during the assigned 26-week treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.

categorical status, descriptive

Other/protocol endpoint/low confidence

Change in plasma IL-6 concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma TNF-alpha concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma IL-1beta concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma CCL2 (MCP-1) concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma CXCL8 (IL-8) concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma IFN-gamma concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma IL-18 concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma IL-17A concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma CXCL10 (IP-10) concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma leptin concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma adiponectin concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma FABP4 concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma resistin concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma visfatin (eNAMPT) concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

Other/protocol endpoint/low confidence

Change in plasma RBP4 concentration after 26 weeks of treatment

Time frame:Treatment start and 26 weeks after treatment start: trial weeks 0 and 26 in Arm A and trial weeks 26 and 52 in Arm B.

change from baseline, improvement

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.