DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT07257484

Not yet recruitingPhase 4

Tirzepatide's Role in Postmenopausal HR+ Breast Cancer Survivors

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

30

estimated

Study population

Obesity / overweight, Oncology

Key I/E criteria

•BMI ≥30•Female

Primary endpoint

•Percentage of participants completing week 24 visit

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07257484
Org study ID25-06029016
Secondary IDKL2TR002385

Timeline

Milestones

Study first posted2025-12-02actual
Last update posted2026-03-13actual
Study start2026-04-06estimated
Primary completion2027-10-06estimated
Study completion2027-12-30estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•Biologically female
•Age ≥ 18
•Obesity as defined by current BMI ≥ 30 kg/m²
•Postmenopausal as defined by one or more of the following
–Age ≥60 years
–Age <60 years with amenorrhea for ≥ 1 year
–Documented bilateral surgical oophorectomy
–Chemical menopause with the addition of LHRH agonists at least 12 weeks prior to enrolment, and plan to remain on LHRH agonists throughout the trial
•HR+ (ER and/or PR) stage 0-III breast cancer
•Completed curative treatment (surgery, chemotherapy, radiotherapy) at least 12 weeks prior to enrolment
•Insurance approval for tirzepatide or willing to pay out of pocket
•Willing to provide informed consent and comply with study procedures

Exclusion criteria

•Stage IV breast cancer
•Concomitant use of CDK inhibitors
•Concomitant use of antiHER2 therapy
•The PI may be consulted regarding enrollment of females receiving other endocrine therapy medications
•Other active malignancy requiring treatment
•Enrollment in another investigational clinical trial
•Contraindication to tirzepatide
•Treatment with a GLP-1 receptor agonist within the last 3 months
•Diabetes requiring insulin
•Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol

Endpoints (20)

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

Glycemic / diabetes
6
Cardiometabolic biomarkers
6
Other (unclassified)
5
Weight & body composition
3

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Percent change in body weight from baseline to week 24

Time frame:Baseline, 24 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in visceral fat mass from baseline to week 24

Time frame:Baseline, 24 weeks

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Percent change in visceral fat mass from baseline to week 24

Time frame:Baseline, 24 weeks

Visceral fat, change

percent change from baseline, improvement

Glycemic / diabetes

6 endpoints
Secondary/protocol endpoint

Absolute change in fasting glucose from baseline to week 24

Time frame:Baseline, 24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percent change in fasting glucose from baseline to week 24

Time frame:Baseline, 24 weeks

Fasting glucose, change

percent change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Absolute change in fasting insulin from baseline to week 24

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Percent change in fasting insulin from baseline to week 24

Time frame:Baseline, 24 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in hemoglobin A1c from baseline to week 24

Time frame:Baseline, 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percent change in hemoglobin A1c from baseline to week 24

Time frame:Baseline, 24 weeks

HbA1c, % change

percent change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Absolute change in leptin from baseline to week 24

Time frame:Baseline, 24 weeks

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Percent change in leptin from baseline to week 24

Time frame:Baseline, 24 weeks

Leptin, change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in adiponectin from baseline to week 24

Time frame:Baseline, 24 weeks

Adiponectin, change

change from baseline, improvement

Secondary/protocol endpoint

Percent change in adiponectin from baseline to week 24

Time frame:Baseline, 24 weeks

Adiponectin, change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in hs-CRP from baseline to week 24

Time frame:Baseline, 24 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Percent change in hs-CRP from baseline to week 24

Time frame:Baseline, 24 weeks

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Other (unclassified)

5 endpoints
Primary/protocol endpoint/low confidence

Percentage of participants completing week 24 visit with all required assessments

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Absolute change in IGF-1 from baseline to week 24

Time frame:Baseline, 24 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Percent change in IGF-1 from baseline to week 24

Time frame:Baseline, 24 weeks

percent change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Absolute change in ghrelin from baseline to week 24

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Percent change in ghrelin from baseline to week 24

Time frame:Baseline, 24 weeks

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 July 1, 2026 snapshot.