Weight-Loss drug may slow uterine tumors before surgery
NCT ID NCT07078838
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether tirzepatide, a drug used for diabetes and weight loss, can slow or stop the growth of early-stage endometrial cancer or its precursor (EIN) in women with obesity. Forty participants will receive either tirzepatide or no additional treatment for 4 weeks before their planned hysterectomy. Researchers will compare tissue samples to see if tirzepatide reduces cell growth in the uterus.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * The subject is willing and able to comply with study procedures based on the judgement of the investigator. * Age \> 18 years at the time of consent. * ECOG ≤ 2 or Karnofsky Performance Status of \>50 * Histological or cytological evidence/confirmation of endometrial intraepithelial neoplasia (EIN) or grade 1 endometrioid histology endometrial cancer (EC) and scheduled to undergo standard of care hysterectomy and staging. * Subject must have archival EC tissue available. * Body mass index of \>30kg/m2 * Demonstrate adequate organ function as defined in the protocol, all screening labs to be obtained within 28 days prior to initiating study treatment Exclusion Criteria: * Active infection requires systemic therapy. * Subject is pregnant or breast breastfeeding, or planning to become pregnant at any time during the study * Taking any prescription medications or other drugs that influence weight change in the past 3 months. * 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 are receiving treatment with insulin. * Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms. * Have a history of acute or chronic pancreatitis or serum lipase/amylase \>2X ULN or fasting triglyceride \>500 mg/dL at screening. * Have a diagnosis of gastroparesis, history of bariatric surgery, or a clinically significant gastric emptying abnormality. * Have a history or family history of multiple endocrine neoplasia, thyroid C-cell hyperplasia, or medullary thyroid carcinoma. * Currently receiving another treatment for EIN or EC. * Any condition, in the opinion of the investigator, which would prohibit safe participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Can a Weight-Loss drug and an IUD treat early uterine cancer without surgery?
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- Can a guided missile for chemo hit tumors harder and spare healthy tissue?
- Can an oral drug that starves tumors help Hard-to-Treat cancers?