Endometrioid Endometrial AdenocarcinomaPhase 2NCT07107334
A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia
A Phase 2 study testing Glucagon-like peptide 1 receptor agonist in people with Endometrioid Endometrial Adenocarcinoma, run by University of Florida at 1 site in United States.
Trial summary
This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrioid Endometrial Adenocarcinoma
- What is being tested?
- Glucagon-like peptide 1 receptor agonist
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to Nov 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- Multiple medical co-morbidities (defined as American Society of Anesthesiologists [ASA] score ≥ 3) at physician discretion
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Amber N Batie, (352) 273-8457, amberbatie@ufl.edu
Laura J Mallinson, (352) 265-5125, coppola@ufl.edu
About this study
Official title: A Pilot Study to Estimate Early Clinical Efficacy Signals of a Glucagon-like Peptide 1 Receptor Agonist (GLP-1RA) Administration in Conjunction With Levonorgestrel Intrauterine Device (LNG-IUD) in Obese Patients With Endometrioid Intraepithelial Neoplasia
This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1. These medications trigger the pancreas to release insulin which can help lower blood sugar levels and delay gastric emptying. The recent FDA approval of GLP-1RAs has changed the landscape for pharmacotherapy for weight loss. These hormone-based obesity medications are novel and revolutionary in obesity medicine. Liraglutine, semaglutide, and tirzepatide have become exceedingly popular for their effects on weight loss and obesity-related comorbidities. More recently, GLP-1RAs have exhibited risk reduction of various obesity associated cancers, including endometrial cancer but their exact role in prevention and treatment has yet to be measured.
- Conditions
- Endometrioid Endometrial Adenocarcinoma
- Being tested
- Glucagon-like peptide 1 receptor agonist
- Keywords
- Endometrial cancer, endometrial intraepithelial neoplasia, endometrial adenocarcinoma, Levonorgestrel IUD
- Medical subject headings
- Endometrial Neoplasms, Endometrial Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-like peptide 1 receptor agonistDrug
Subjects will receive a glucagon-like peptide 1 receptor agonist (either semaglutide, tirzepatide or liraglutide) by self-injection or orally (semaglutide or orforglipron) for as clinically indicated by the treating physician or until the subject receives clearance for staging hysterectomy or for pregnancy pursuit. The choice of glucagon-like peptide 1 receptor agonist for each subject will be at the treating physician's discretion.
Subjects will discontinue the glucagon-like peptide 1 receptor agonist 2 weeks before any elective surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Glucagon-like peptide 1 receptor agonist | Experimental | Not described Receives: Drug: Glucagon-like peptide 1 receptor agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from start of GLP-1RA to clearance of staging hysterectomy
Determine the time from start of GLP-1RA treatment to clearance for staging hysterectomy in patients with poor surgical candidacy for a hysterectomy.
Measured: 12 months
Time from start of GLP-1RA to clearance for pregnancy pursuit
Determine the time from start of GLP-1RA treatment to clearance for pregnancy pursuit in patients pursuing fertility sparing.
Measured: 12 months
Endometrial pathologic response
Determine the endometrial pathologic response 6 months after beginning GLP-1RA treatment
Measured: 6 months after beginning GLP-1RA treatment
Endometrial pathologic response
Determine the endometrial pathologic response 12 months after beginning GLP-1RA treatment
Measured: 12 months after beginning GLP-1RA treatment
Secondary outcomes (6)
Length of surgery
Determine the length of staging hysterectomy surgery
Measured: Intraoperative
Number of nights in hospital
Determine the number of nights spent in the hospital for staging hysterectomy
Measured: 12 months
Postoperative complications
Determine the postoperative complications following staging hysterectomy
Measured: 12 months
Patient-reported quality of life
Compare patient-reported quality of life, as measured by the EORTC QLQ-C30, v3.0 between baseline and at 6 months after beginning GLP-1RA treatment
Measured: 6 months
Patient-reported quality of life
Compare patient-reported quality of life, as measured by the EORTC QLQ-C30, v3.0 between baseline and at 12 months after beginning GLP-1RA treatment
Measured: 12 months
Patient-reported quality of life
Compare patient-reported quality of life, as measured by the EORTC QLQ-C30, v3.0 between baseline and at end of GLP-1RA treatment
Measured: at either clearance for pregnancy pursuit or staging hysterectomy, which will ideally occur by 12 months after beginning study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start7 Apr 2026
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrioid Endometrial AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kaitlin Nicholson, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07107334
- Sponsor's protocol ID
- UF-GYN-003
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No