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Tirzepatide in the Treatment of Endometrial Cancer

NCT07605247 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-22

No results posted yet for this study

Summary

This study is looking for a better way to treat pre-cancer or early-stage cancer in the lining of the uterus in women who are also overweight.

Everyone in the study will receive the standard treatment, a Progesterone IUD (LNG-IUD). This device is put in the uterus and releases hormones to help fight the disease. We will add a new medicine, Tirzepatide, for some people. Tirzepatide is a shot that helps with weight loss and overall health. You will be placed into one of two groups by chance (like flipping a coin):

1. Group 1: You get the Progesterone IUD PLUS the Tirzepatide shot.
2. Group 2: You get the Progesterone IUD ONLY (Standard Treatment).

During the study, you will be asked to fill out surveys often. These questions ask about your daily life, how you feel about your health and weight, and any side effects you might have. This helps us understand how the treatments affect you. You will have small tissue samples (biopsies) taken from your uterus at different times. This is how doctors check at 12 months (one year) if the pre-cancer or cancer cells are completely gone. The schedules for visits, tests, and monitoring will be identical for both groups to ensure fairness.

If this study is successful, it could mean that women who are overweight with these conditions can get a better treatment that gets rid of the disease and still allows them to keep their ability to have children (avoids surgery). It may also improve their overall health through weight loss.

Conditions

Interventions

DRUG

Tirzepatide

Phase I (Months 0-3): All participants receive LNG-IUD alone

DEVICE

LNG-IUD plus tirzepatide

Phase II (Months 3-9): All participants continue LNG-IUD plus tirzepatide (titrated to maximally tolerated dose).

Sponsors & Collaborators

  • Rutgers, The State University of New Jersey

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-01-31
Completion
2028-01-31
FDA Drug
Yes
FDA Device
Yes

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07605247 on ClinicalTrials.gov