Tirzepatide + Progestin IUD for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if adding tirzepatide injections to a levonorgestrel IUD improves treatment outcomes for women with certain early-stage uterine conditions. These conditions include endometrial atypical hyperplasia or grade 1 endometrial cancer, which can worsen with excess weight. Researchers are testing tirzepatide, a weight-loss injection, and the levonorgestrel IUD, a hormone-releasing device, together to see if they reduce cancer cells in tissue samples. Women who are overweight or obese, diagnosed with one of these conditions, and prefer a non-surgical approach might be suitable for this study. As a Phase 2 trial, this study measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important medical research.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tirzepatide is generally well-tolerated. Studies indicate that the cancer risk for those taking tirzepatide is similar to those not taking it, suggesting it does not increase cancer risk. One study found it helped reduce tumor size in mice, which is promising for its potential in cancer treatments.
For the levonorgestrel intrauterine device (LNG-IUD), research has shown it to be a safe and effective treatment. Trials have shown no side effects and suggest it may lower the risk of endometrial cancer. The LNG-IUD is often used in cancer prevention and management and has a good safety record.
Overall, both tirzepatide and the LNG-IUD have demonstrated positive safety profiles in research.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of tirzepatide and a progestin IUD for endometrial cancer because it brings a fresh approach to treatment. Unlike traditional methods that often involve surgery or standard hormone therapies, this combination leverages tirzepatide, a new drug that acts on both GLP-1 and GIP receptors, which are pathways not typically targeted in endometrial cancer. This dual-action could potentially lead to better weight management and improved metabolic health, which are important factors in cancer treatment. Additionally, using a progestin IUD provides localized hormone delivery, which may reduce systemic side effects typically associated with oral or injectable hormone therapies.
What evidence suggests that this trial's treatments could be effective for endometrial cancer?
Research shows that tirzepatide, which participants in this trial will receive, can aid in weight loss, an important factor since obesity is linked to endometrial cancer. Studies have found that tirzepatide can reduce tumor size and may slow tumor growth in obesity-related cancers. Meanwhile, the levonorgestrel intrauterine device (LNG-IUD), also included in this trial, has been shown to lower the risk of endometrial cancer. Specifically, one study found that using the LNG-IUD led to a 93% reduction in abnormal thickening of the uterine lining. This trial will evaluate the combination of these treatments to potentially improve outcomes for women with early-stage endometrial cancer or precancerous conditions.24678
Who Is on the Research Team?
Roni N Wilke
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for overweight or obese women with endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) or grade 1 endometrial cancer. It's designed to see if a combination of tirzepatide injections and a levonorgestrel-releasing intrauterine device can improve treatment outcomes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo LNG-IUD placement and receive tirzepatide injections weekly for 26 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Extension
Participants may continue treatment with tirzepatide or another weight loss medication beyond 26 weeks as per standard of care
What Are the Treatments Tested in This Trial?
Interventions
- Progestin Intrauterine Device
- Tirzepatide
Trial Overview
The study is testing the effectiveness of adding tirzepatide, a medication that promotes weight loss, to the standard use of an intrauterine device releasing levonorgestrel hormone in treating early-stage endometrial conditions without surgery.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Patients undergo LNG-IUD placement at baseline or on day 0 and then receive tirzepatide SC QW for 26 weeks in the absence of disease progression or unacceptable toxicity. Patients who qualify for tirzepatide or another weight loss medication as determined by primary provider may continue to receive treatment beyond 26 weeks as per standard of care. Additionally, patients undergo cervical culture sample collection, chest x-ray, and MRI or CT with transvaginal ultrasound during screening and blood sample collection and EMB throughout the study. Patients may also undergo D\&C during screening.
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
Levonorgestrel-releasing intrauterine device therapy vs oral ...
This meta-analysis provides data on the effectiveness of oral progestins and levonorgestrel-releasing IUD treatment within 12 months of treatment
Levonorgestrel-releasing Intrauterine Device Alone for ...
In this study, treatment with levonorgestrel-releasing intrauterine device alone showed promising results. Hemoglobin levels stayed stable or ...
Complete pathological response following levonorgestrel ...
Intrauterine levonorgestrel (LNG-IUD) is used to treat patients with endometrial adenocarcinoma. (EAC) and endometrial hyperplasia with atypia (EHA) but limited ...
Association of levonorgestrel-releasing intrauterine device ...
Women who used LNG-IUD have a 33% reduced risk of endometrial cancer. LNG-IUD use is associated with a 14% lower risk of cervical cancer and a 9 ...
Comparison of the effectiveness of the levonorgestrel ...
The primary treatment with LNG-IUD showed a 93% regression rate of endometrial hyperplasia, which was significantly higher than oral progestogens showing a 66% ...
LNG-IUS combined with progesterone ameliorates ...
LNG-IUS combined with progesterone ameliorates endometrial thickness and pregnancy outcomes of patients with early-stage endometrial cancer or atypical ...
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international-journal-of-gynecological-cancer.com
international-journal-of-gynecological-cancer.com/article/S1048-891X(25)01907-3/fulltextLevonorgestrel-releasing intra-uterine device alone for ...
Levonorgestrel-releasing intra-uterine device alone is a safe and effective approach, showing no side effects, and a promising oncological outcome in women with ...
Value of LNG-IUS as Fertility-preserving Treatment of EAH ...
This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena®) in the fertility-sparing treatment ...
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