Adding a GLP‑1 weight‑loss medicine to a levonorgestrel IUD for obese patients with endometrial precancer or low‑grade cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial enrolls adults with recent pathology showing endometrial intraepithelial neoplasia or grade 1 endometrioid endometrial adenocarcinoma who are obese (BMI ≥ 30) and are poor surgical candidates or seeking fertility preservation. Participants receive a levonorgestrel intrauterine device together with a glucagon‑like peptide‑1 receptor agonist and are followed with pathology review and imaging to look for early signs of treatment response. External pathology is confirmed in‑house before enrollment, and imaging is used to ensure no myometrial invasion or extrauterine spread. The trial focuses on safety and early clinical efficacy signals rather than definitive cure rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults ≥ 18 years old
* A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN
* For subjects with a diagnosis of endometrial intraepithelial neoplasia/grade 1 endometrioid endometrial adenocarcinoma prior to enrollment in the study, and with a diagnosis made outside this institution, the diagnostic material originating from outside the study site will undergo in-house pathology review before enrollment acceptance.
* ECOG Performance Status of 0 to 3
* For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound
* BMI ≥ 30 kg/m2 and one of the following (per medical record or self-report):

  1. Multiple medical co-morbidities (defined as American Society of Anesthesiologists \[ASA\] score ≥ 3) at physician discretion
  2. Fertility desire
* Subject has had appropriate age-related breast examinations and imagining prior to study enrollment, as documented in the medical record or via investigator confirmation.
* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

Exclusion Criteria:

* Subjects with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous)
* Clinical suspicion of metastatic disease as assessed by the treating physician or confirmed metastatic disease based on imaging
* Subjects with abnormal cervical cytology
* Subjects who are diagnosed with thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2
* Subjects who are confirmed to be pregnant or breastfeeding
* History of medullary thyroid cancer
* Subjects with known current or history of hormonally- sensitive carcinoma (e.g., breast, melanoma)
* Subjects actively taking GLP-1RA for more than 14 days at time of consent.
* Subjects with levonorgestrel-releasing intrauterine system placed \>45 days prior to study enrollment.
* Subjects must not have more than one active malignancy at the time of enrollment (Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with safety or efficacy assessment of the study \[as determined by the treating physician or approved by the PI\] may be included).
* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. This includes, but is not limited to, conditions such as New York Heart Association (NYHA) Class IV heart failure.
* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Where it's running

• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Kaitlin Nicholson, MD — University of Florida
• Study coordinator: Amber N Batie
• Email: amberbatie@ufl.edu
• Phone: (352) 273-8457

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating dostarlimab as a non-surgical treatment for early-stage endometrial cancer

  This study is testing if a new immunotherapy drug called dostarlimab can be a safe and effective non-surgical treatment for women with early-stage endometrial cancer who want to keep their fertility or can't have surgery.

  Recruiting at 2 sites Phase 2 Queensland Centre for Gynaecological Cancer · Sydney, New South Wales and 2 other locations · NCT06278857

• Progestins before surgery for endometrial cancer or precancers

  This phase II study tests two progestin options (megestrol acetate vs. micronized progesterone) for women with endometrial cancer or atypical endometrial hyperplasia before they have surgery.

  Recruiting at 2 sites Phase 2 New Mexico Cancer Research Alliance · Iowa City, Iowa and 3 other locations · NCT07436793

• Combining ONC201 and Atezolizumab for treating obesity-related endometrial cancer

  This study is testing a new treatment for advanced or recurrent endometrial cancer in obese women by combining two drugs, ONC201 and atezolizumab, to see if it helps manage their cancer better.

  Recruiting Phase 1 UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT05542407

• Testing nivolumab with or without ipilimumab for recurrent endometrial cancer

  This study is testing if adding ipilimumab to nivolumab can help people with recurrent endometrial cancer live longer and feel better compared to just using nivolumab alone.

  Recruiting at 122 sites Phase 2 National Cancer Institute (NCI) · Birmingham, Alabama and 137 other locations · NCT05112601

• Short course vaginal cuff brachytherapy for early-stage endometrial cancer

  This study is testing if a shorter type of radiation treatment for early-stage endometrial cancer is just as effective as the standard longer treatment, while also looking at how it affects patients' quality of life and other factors.

  Recruiting at 3 sites Phase 3 University of Utah · Palo Alto, California and 4 other locations · NCT03422198

• Molecular and ctDNA profiling for high-risk endometrial cancer

  This project will collect blood and tumor tissue to test whether tumor DNA and other genetic changes can help predict recurrence in people with high-risk endometrial cancer.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07062016

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.