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Weight-Loss drug may slow uterine tumors before surgery

NCT ID NCT07078838

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.