A Phase 2 interventional study of Semaglutide (Wegovy®) in Breast Cancer (Early Breast Cancer) and Obesity, sponsored by Aarhus University Hospital. Not yet recruiting at 2 sites in Denmark. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Aarhus University Hospital · Phase 2, Interventional, and Treatment
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.
WISPER is a phase II, randomized, open-label, single-center, delayed-start feasibility trial conducted at the Department of Oncology, Aarhus University Hospital, Denmark. Thirty-two women aged 18 years or older with obesity (body mass index at least 30 kg/m²) and stage I-III estrogen receptor-positive breast cancer will be randomized 1:1 to immediate or delayed semaglutide initiation. Participants must be receiving, or planning to initiate, adjuvant endocrine therapy with at least 78 weeks of planned treatment remaining at randomization.
The immediate-start arm receives once-weekly subcutaneous semaglutide for 26 weeks starting at randomization, followed by 26 weeks of post-treatment observation. The delayed-start arm receives standard care for 26 weeks, followed by the same 26-week semaglutide regimen and 26 weeks of post-treatment observation. Semaglutide is escalated from 0.25 mg weekly to a target dose of 2.4 mg weekly. Delayed escalation or temporary dose reduction is permitted for tolerability. Both arms continue usual adjuvant endocrine therapy and receive standardized written guidance on diet and physical activity without a supervised lifestyle intervention.
The primary endpoint is a composite feasibility outcome at the end of each arm's 26-week treatment phase: completion of treatment without permanent discontinuation of adjuvant endocrine therapy or semaglutide, with administration of at least 21 of 26 planned weekly semaglutide injections.
Secondary assessments address safety, patient-reported tolerability, recruitment, retention, treatment completion and acceptability, as well as changes in weight, metabolic measures, body composition and quality of life. The randomized comparison during the first 26 weeks contrasts immediate treatment with the waiting period. Additional assessments evaluate each arm's treatment period and subsequent weight maintenance. Exploratory analyses concern semaglutide and endocrine-therapy pharmacokinetics and exposure-response relationships. Stored samples may be used for protocol-specified exploratory biomarker analyses in participants who consent to biobanking.
Trial weeks are measured from randomization. Treatment starts at trial week 0 in the immediate-start arm and trial week 26 in the delayed-start arm. End-of-treatment assessments occur at trial weeks 26 and 52, respectively; end-of-follow-up assessments occur at trial weeks 52 and 78. Participants who discontinue semaglutide are invited to continue scheduled follow-up.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 32 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Aarhus University Hospital is the lead sponsor of 298 studies on the registry; 80 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Significant somatic disease, defined as any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive semaglutide once weekly for 26 weeks starting at randomization, followed by 26 weeks of post-treatment observation. Usual adjuvant endocrine therapy, routine oncology follow-up and standardized written guidance on diet and physical activity continue throughout participation.
Drug: Semaglutide (Wegovy®)
Participants receive standard care alone for the first 26 weeks after randomization, then semaglutide once weekly for 26 weeks, followed by 26 weeks of post-treatment observation. Standard care comprises usual adjuvant endocrine therapy, routine oncology follow-up and standardized written guidance on diet and physical activity. Total follow-up is 78 weeks from randomization.
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.
Also known as: Wegovy
Completion of the 26-week semaglutide treatment phase meeting all composite feasibility criteria
Percentage of participants who complete the assigned 26-week treatment phase while meeting all three criteria: no permanent discontinuation of prescribed adjuvant endocrine therapy; no permanent discontinuation of semaglutide; and administration of at least 21 of 26 planned weekly semaglutide injections. Endocrine therapy continuation is assessed from prescription records and self-reported intake; semaglutide adherence is assessed from electronic dosing diaries with pen reconciliation. The proportion will be reported with a 95% confidence interval.
Time frame: At completion of 26 weeks of semaglutide treatment: trial week 26 in Arm A and trial week 52 in Arm B.
Adverse events during semaglutide treatment and post-treatment follow-up
Number and percentage of participants with adverse events and total number of events, characterized by event type, maximum severity according to CTCAE version 6.0, relationship to semaglutide and event outcome.
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.
Serious adverse events
Number and percentage of participants with at least one serious adverse event and total number of serious adverse events during trial participation.
Time frame: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Suspected unexpected serious adverse reactions
Number and percentage of participants with at least one suspected unexpected serious adverse reaction and total number of such reactions during trial participation.
Time frame: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Adverse events of special interest
Number and percentage of participants with protocol-defined adverse events of special interest and number of events, reported separately by event category.
Time frame: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Patient-reported symptomatic adverse events
Patient-reported symptomatic adverse events assessed using selected PRO-CTCAE items, with frequency, severity, interference or presence reported separately as applicable. Item scores range from 0 to 4, or 0 to 1 for presence/absence, with higher values indicating greater symptom burden.
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.
Semaglutide dose interruptions
Number and percentage of participants with a temporary interruption of semaglutide, number of interruptions and recorded reasons.
Time frame: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Semaglutide dose reductions
Number and percentage of participants with a reduction in semaglutide dose, number of dose reductions and recorded reasons.
Time frame: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Permanent discontinuation of semaglutide
Number and percentage of participants who permanently discontinue semaglutide, with reasons for discontinuation.
Time frame: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Time to permanent discontinuation of semaglutide
Time in days from the first semaglutide dose to permanent discontinuation during the assigned treatment phase.
Time frame: During the 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Permanent discontinuation of adjuvant endocrine therapy
Number and percentage of participants who permanently discontinue adjuvant endocrine therapy, with reasons for discontinuation. Temporary interruptions or modifications with maintained prescribing intent are not classified as permanent discontinuation.
Time frame: From randomization to end of follow-up: up to 52 weeks in Arm A and 78 weeks in Arm B.
Completion of the semaglutide treatment phase
Percentage of participants who complete the assigned 26-week semaglutide treatment phase, summarized separately by arm.
Time frame: At trial week 26 in Arm A and trial week 52 in Arm B.
Participant-reported acceptability of semaglutide treatment
Qualitative themes from semi-structured interviews concerning acceptability, motivation, expectations, concerns, perceived stigma, support needs and barriers to participation. Approximately 10 participants across both arms are expected to be interviewed.
Time frame: After treatment completion, within trial weeks 26-52 in Arm A and 52-78 in Arm B.
Participants achieving at least 5% weight loss at trial week 26
Percentage of participants with at least 5% reduction in body weight from randomization baseline to trial week 26, compared between the immediate-start and delayed-start arms. Weight loss is calculated relative to body weight at randomization.
Time frame: From randomization to trial week 26 in both arms.
Percentage change in body weight from randomization to trial week 12
Mean percentage change in body weight from randomization baseline to trial week 12, representing early treatment in Arm A and the waiting period in Arm B. Negative values indicate weight loss.
Time frame: Randomization baseline and trial week 12 in both arms.
Change in fat mass after 26 weeks of treatment
Fat mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg.
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 in fat mass percentage after 26 weeks of treatment
Fat mass as a percentage of total body weight, measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: percentage points.
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 in fat-free mass after 26 weeks of treatment
Fat-free mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg.
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 in fat-free mass percentage after 26 weeks of treatment
Fat-free mass as a percentage of total body weight, measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: percentage points.
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 in skeletal muscle mass after 26 weeks of treatment
Skeletal muscle mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: kg.
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 in EORTC QLQ-C30 Global Health Status and Quality of Life score
Change in the EORTC QLQ-C30 Global Health Status/Quality of Life scale score from treatment start to treatment completion. Scores range from 0 to 100; higher scores indicate better global health status and quality of life. Positive changes indicate improvement.
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 in EORTC QLQ-BR45 Body Image score
Change in the EORTC QLQ-BR45 Body Image scale score from treatment start to treatment completion. Scores range from 0 to 100; higher scores indicate better body image. Positive changes indicate improvement.
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 in fasting plasma glucose after 26 weeks of treatment
Fasting plasma glucose, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmol/L.
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 in total cholesterol after 26 weeks of treatment
Total cholesterol, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmol/L.
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Longitudinal change in waist circumference
Waist circumference, expressed as change from the value immediately before semaglutide initiation at each scheduled full assessment through the end of post-treatment follow-up. Unit of change: cm.
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.
Longitudinal change in hip circumference
Hip circumference, expressed as change from the value immediately before semaglutide initiation at each scheduled full assessment through the end of post-treatment follow-up. Unit of change: cm.
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.
Longitudinal change in waist-to-hip ratio
Waist circumference divided by hip circumference, expressed as change from the value immediately before semaglutide initiation at each scheduled full assessment through the end of post-treatment follow-up. Unit of change: unitless 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.
Longitudinal change in fat mass
Fat mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation at each scheduled full assessment through the end of post-treatment follow-up. Unit of change: kg.
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.
Longitudinal change in fat mass percentage
Fat mass as a percentage of total body weight, measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation at each scheduled full assessment through the end of post-treatment follow-up. Unit of change: percentage points.
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.
Longitudinal change in fat-free mass
Fat-free mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation at each scheduled full assessment through the end of post-treatment follow-up. Unit of change: kg.
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.
Longitudinal change in fat-free mass percentage
Fat-free mass as a percentage of total body weight, measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation at each scheduled full assessment through the end of post-treatment follow-up. Unit of change: percentage points.
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.
Longitudinal change in skeletal muscle mass
Skeletal muscle mass measured by multi-frequency segmental bioelectrical impedance analysis, expressed as change from the value immediately before semaglutide initiation at each scheduled full assessment through the end of post-treatment follow-up. Unit of change: kg.
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.
Apparent clearance of semaglutide
Population pharmacokinetic estimate of apparent semaglutide clearance following subcutaneous administration (CL/F), expressed in L/hour.
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.
Apparent volume of distribution of semaglutide
Population pharmacokinetic estimate of apparent semaglutide volume of distribution following subcutaneous administration (V/F), expressed in L.
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.
Recruitment proportion
Percentage of screened, eligible patients who provide consent and are randomized, based on the screening log.
Time frame: Throughout the recruitment period, approximately 12 months.
Consent proportion
Percentage of eligible patients approached for participation who agree to participate, based on the recruitment and screening records.
Time frame: Throughout the recruitment period, approximately 12 months.
Participant retention
Percentage of randomized participants who complete the end-of-trial visit, summarized separately by randomized arm.
Time frame: At trial week 52 in Arm A and trial week 78 in Arm B.
Change in resting pulse rate after 26 weeks of treatment
Resting pulse rate, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: beats per minute.
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 in LDL cholesterol after 26 weeks of treatment
Low-density lipoprotein cholesterol, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmol/L.
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 in HDL cholesterol after 26 weeks of treatment
High-density lipoprotein cholesterol, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmol/L.
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 in triglycerides after 26 weeks of treatment
Triglycerides, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmol/L.
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 in C-reactive protein after 26 weeks of treatment
C-reactive protein, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mg/L.
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Participants achieving at least 10% weight loss after 26 weeks of treatment
Percentage of participants with at least 10% reduction in body weight relative to body weight immediately before semaglutide initiation, evaluated separately in each arm.
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Percentage change in body weight from randomization to trial weeks 26 and 52
Mean percentage change in body weight from randomization baseline, summarized at trial weeks 26 and 52 in each arm. Percentage change is 100 multiplied by follow-up weight minus baseline weight, divided by baseline weight. Negative values indicate weight loss.
Time frame: Randomization baseline and trial weeks 26 and 52 in both arms.
Change in body weight during post-treatment observation
Change in body weight in kilograms from the end of semaglutide treatment to the end of the 26-week post-treatment observation period, summarized separately by arm. Positive values indicate weight regain.
Time frame: Trial weeks 26-52 in Arm A and trial weeks 52-78 in Arm B.
Change in resting systolic blood pressure after 26 weeks of treatment
Resting systolic blood pressure, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmHg.
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 in resting diastolic blood pressure after 26 weeks of treatment
Resting diastolic blood pressure, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmHg.
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 in waist-to-hip ratio after 26 weeks of treatment
Waist circumference divided by hip circumference, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: unitless ratio.
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 in hip circumference after 26 weeks of treatment
Hip circumference, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: cm.
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 in waist circumference after 26 weeks of treatment
Waist circumference, expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: cm.
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 in HbA1c after 26 weeks of treatment
Glycated hemoglobin (HbA1c), expressed as change from the value immediately before semaglutide initiation to the end of the 26-week treatment phase. Unit of change: mmol/mol.
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 in body mass index after 26 weeks of treatment
Change in body mass index, expressed in kg/m², from immediately before semaglutide initiation to the end of the 26-week treatment phase.
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Participants achieving at least 15% weight loss after 26 weeks of treatment
Percentage of participants with at least 15% reduction in body weight relative to body weight immediately before semaglutide initiation, evaluated separately in each arm.
Time frame: From treatment start to 26 weeks after treatment start: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Model-predicted average steady-state semaglutide concentration
Individual model-predicted average steady-state plasma semaglutide concentration (Cavg,ss), in nmol/L, standardized to a reference dose of 2.4 mg subcutaneously once weekly. Cavg,ss is calculated as the model-predicted area under the concentration-time curve over a 168-hour dosing interval divided by 168 hours. Estimates are derived from population pharmacokinetic modelling using measured concentrations and recorded dosing and sampling times. The geometric mean and between-participant variability will be described.
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.
Semaglutide exposure by concomitant endocrine therapy class
Ratio of model-predicted average steady-state semaglutide concentrations between participants receiving tamoxifen and participants receiving an aromatase inhibitor, standardized to semaglutide 2.4 mg once weekly. The tamoxifen-to-aromatase-inhibitor geometric mean ratio will be estimated using endocrine therapy class as a population pharmacokinetic model covariate. Endocrine therapy at each sample and treatment changes will be recorded. Estimates will be reported with uncertainty where estimable.
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.
Plasma tamoxifen concentrations during concomitant semaglutide treatment
Measured plasma tamoxifen concentration, in ng/mL, in participants receiving tamoxifen. Concentrations will be summarized separately at each assessment. Time since the most recent endocrine therapy dose, prescribed dose and treatment changes will be recorded to support interpretation.
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.
Plasma endoxifen concentrations during concomitant semaglutide treatment
Measured plasma endoxifen concentration, in ng/mL, in participants receiving tamoxifen. Concentrations will be summarized separately at each assessment. Time since the most recent endocrine therapy dose, prescribed dose and treatment changes will be recorded to support interpretation.
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.
Plasma 4-hydroxytamoxifen concentrations during concomitant semaglutide treatment
Measured plasma 4-hydroxytamoxifen concentration, in ng/mL, in participants receiving tamoxifen. Concentrations will be summarized separately at each assessment. Time since the most recent endocrine therapy dose, prescribed dose and treatment changes will be recorded to support interpretation.
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.
Plasma letrozole concentrations during concomitant semaglutide treatment
Measured plasma letrozole concentration, in ng/mL, in participants receiving letrozole. Concentrations will be summarized separately at each assessment. Time since the most recent endocrine therapy dose, prescribed dose and treatment changes will be recorded to support interpretation.
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.
Association between semaglutide exposure and percentage weight change
Spearman rank correlation between model-predicted average plasma semaglutide concentration over the 26-week treatment phase and percentage change in body weight from treatment start to treatment completion. Average concentration is the model-predicted area under the concentration-time curve over 26 weeks divided by the corresponding duration and incorporates recorded dosing, interruptions and discontinuation. Percentage weight change is 100 × (end-of-treatment weight - treatment-start weight) / treatment-start weight.
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.
Association between semaglutide exposure and adverse event count
Spearman rank correlation between individual model-predicted average steady-state semaglutide concentration at a reference dose of 2.4 mg once weekly and the number of distinct adverse event episodes recorded during the assigned 26-week treatment phase. Events are clinician-assessed using CTCAE version 6.0. Repeated assessments of an ongoing event are counted as one episode. This exploratory measure describes an association with pharmacokinetic exposure propensity rather than a causal effect of administered dose.
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.
Association between semaglutide exposure and temporary treatment interruptions
Spearman rank correlation between individual model-predicted average steady-state semaglutide concentration at a reference dose of 2.4 mg once weekly and the number of temporary semaglutide treatment interruptions during the assigned treatment phase. A continuous interruption is counted as one episode. Permanent discontinuation is evaluated separately.
Time frame: During the assigned 26-week semaglutide treatment phase: trial weeks 0-26 in Arm A and 26-52 in Arm B.
Semaglutide exposure by permanent treatment discontinuation status
Ratio of geometric mean model-predicted average steady-state semaglutide concentrations between participants who permanently discontinue semaglutide during the assigned treatment phase and participants who do not. Concentrations are standardized to a reference dose of 2.4 mg once weekly. The discontinuation-to-no-discontinuation ratio will be reported with uncertainty where estimable. Participants without an estimable pharmacokinetic exposure are described separately.
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.
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
Change in plasma IFN-beta 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 in plasma IL-6 concentration after 26 weeks of treatment
Change in plasma interleukin-6 (IL-6) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma TNF-alpha concentration after 26 weeks of treatment
Change in plasma tumor necrosis factor alpha (TNF-α) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma IL-1beta concentration after 26 weeks of treatment
Change in plasma interleukin-1 beta (IL-1β) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma CCL2 (MCP-1) concentration after 26 weeks of treatment
Change in plasma CCL2 (monocyte chemoattractant protein-1; MCP-1) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma CXCL8 (IL-8) concentration after 26 weeks of treatment
Change in plasma CXCL8 (interleukin-8; IL-8) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma IFN-gamma concentration after 26 weeks of treatment
Change in plasma interferon gamma (IFN-γ) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma IL-18 concentration after 26 weeks of treatment
Change in plasma interleukin-18 (IL-18) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma IL-17A concentration after 26 weeks of treatment
Change in plasma interleukin-17A (IL-17A) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma CXCL10 (IP-10) concentration after 26 weeks of treatment
Change in plasma CXCL10 (interferon gamma-induced protein 10; IP-10) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using MSD electrochemiluminescence immunoassays suitable for the selected analyte and plasma matrix.
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 in plasma leptin concentration after 26 weeks of treatment
Change in plasma leptin concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using an immunoassay suitable for the selected analyte and plasma matrix.
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 in plasma adiponectin concentration after 26 weeks of treatment
Change in plasma adiponectin concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using an immunoassay suitable for the selected analyte and plasma matrix.
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 in plasma FABP4 concentration after 26 weeks of treatment
Change in plasma fatty acid-binding protein 4 (FABP4) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using an immunoassay suitable for the selected analyte and plasma matrix.
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 in plasma resistin concentration after 26 weeks of treatment
Change in plasma resistin concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using an immunoassay suitable for the selected analyte and plasma matrix.
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 in plasma visfatin (eNAMPT) concentration after 26 weeks of treatment
Change in plasma visfatin (extracellular nicotinamide phosphoribosyltransferase; eNAMPT) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using an immunoassay suitable for the selected analyte and plasma matrix.
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 in plasma RBP4 concentration after 26 weeks of treatment
Change in plasma retinol-binding protein 4 (RBP4) concentration from immediately before semaglutide initiation to completion of the 26-week treatment phase. Concentrations will be measured in stored biobank plasma samples. Measurement is planned using an immunoassay suitable for the selected analyte and plasma matrix.
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.
Plan to share: No — There is no plan to share individual participant data outside the study team.
No publications or documents are linked to this record.
Start is estimated for Mar 2027; primary completion for Mar 2029, 24 months later.
Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's planned 24 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide