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RecruitingPhase EARLY_1

Tirzepatide in Obesity-Driven Endometrial Cancer

A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Enrollment

20

estimated

Study population

Obesity / overweight, Oncology

Key I/E criteria

BMI ≥30Female

Primary endpoint

Proliferation

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 IDNCT07065552
Org study IDLCCC2415

Timeline

Milestones

Study first posted2025-07-15actual
Study start2026-04-27actual
Last update posted2026-04-28actual
Primary completion2028-07estimated (month precision)
Study completion2028-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging.
Agree to comply with all required study assessments and visits including internet capabilities.
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Age ≥ 18 at the time of consent.
Body mass index of ≥30 kg/m2.
Presumed clinically early-stage disease (disease confined to uterus only).
ECOG ≤ 2 or Karnofsky Performance Status of > 50

Exclusion criteria

Active infection requiring systemic therapy.
Subject is pregnant or breast feeding.
Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.
Taking a central nervous system stimulant.
Current psychological conditions that would be incompatible with participation in this study, as determined by investigator.
Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists.
Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or receiving treatment with insulin.
Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.

Endpoints (14)

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
4
Other (unclassified)
4
Weight & body composition
2
Cardiometabolic biomarkers
2
MASH / liver
1
Other clinical outcomes
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Improvement in waist-to-hip ratio

Time frame:Baseline - Up to 6 weeks

change from baseline, improvement

Secondary/protocol endpoint

Improvement in Body Mass Index

Time frame:Baseline - Up to 6 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Improvement in Diabetes

Time frame:Baseline - Up to 6 weeks

categorical status, improvement

Secondary/protocol endpoint

Improvement in HgbA1C level

Time frame:Baseline - Up to 6 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in insulin

Time frame:Baseline - Up to 6 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in glucose

Time frame:Baseline - Up to 6 weeks

change from baseline, improvement

MASH / liver

1 endpoint
Secondary/protocol endpoint

Change in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), and Gamma-Glutamyl Transferase (GGT) levels

Time frame:Baseline - Up to 6 weeks

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in circulating levels of inflammatory cytokines

Time frame:Baseline - Up to 6 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Lipids

Time frame:Baseline - Up to 6 weeks

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Change in sex hormones

Time frame:Baseline - Up to 6 weeks

Androgen, change

change from baseline, improvement

Other (unclassified)

4 endpoints
Primary/protocol endpoint/low confidence

Change in Proliferation

Time frame:Baseline - Up to 6 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Insulin-like Growth Factor 1

Time frame:Baseline - Up to 6 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Apoptosis

Time frame:Baseline - Up to 6 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Ribonucleic Acid (RNA) sequence

Time frame:Baseline - Up to 6 weeks

change from baseline, descriptive

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.