Tirzepatide in the Treatment of Endometrial Cancer

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07605247
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Phase I (Months 0-3): All participants receive LNG-IUD alone
  • LNG-IUD plus tirzepatide — DEVICE
    Phase II (Months 3-9): All participants continue LNG-IUD plus tirzepatide (titrated to maximally tolerated dose).

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: LNG-IUD + Tirzepatide
    This is a multicenter, open-label, prospective, single-arm phase II pilot trial using a sequential design to evaluate the addition of tirzepatide to LNG-IUD in women with obesity and premalignant or early-stage endometrioid endometrial pathology.

Primary Outcome Measure

Quality of Life Quality of life will be measured through PROMs at the time points listed below for explorative purposes. [ Time Frame: ● Screening (day -30 to Week 0) ● 3 months (Visit 4, Week 12) ● 6 months (Visit 7, Week 24) ● 9 months (Visit 10, Week 36) ]

Central Contacts

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