Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07349641 · ClinicalTrials.gov registry record · Phase 2
A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Not yet
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT07349641: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT07349641 is a Phase 2 study that has not yet begun recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07349641, a Phase 2 study, has not yet begun recruiting, sponsored by National Cancer Institute (NCI).
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
This phase II trial studies whether adding tirzepatide injections to a levonorgestrel intrauterine device (LNG-IUD) improves pathologic response (absence of cancer cells in tissue samples after treatment) in women with endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) or grade 1 endometrial cancer who are overweight or obese. Endometrial cancer occurrence has continued to rise in the United States. Over half of endometrial cancer cases are thought to be attributable to being overweight and obese, and the risk relationship appears to be weight dependent. AH/EIN is a precancerous condition of the endometrium (the uterus or womb) where the lining of the uterus grows abnormally thick, and the cells become abnormal. Women with this thickening have a higher-than-average risk of developing endometrial cancer if left untreated. The usual approach for patients who have AH/EIN and grade 1 endometrial cancer is the removal of the uterus. While surgical treatment is generally safe and effective, it may not be the best approach for some patients. The LNG-IUD is a small, T-shaped device inserted into the uterus that releases the hormone levonorgestrel, a progestin, which counteracts the effects of estrogen in the endometrium. Tirzepatide is a dual glucagon-like peptide 1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) agonist which has been shown to drive weight loss. Adding tirzepatide injections to LNG-IUD may help overweight or obese women with AH-EIN or grade 1 endometrial cancer lose weight, which may improve pathologic response.
Interventions
- DRUG Tirzepatide
- OTHER Medical Device Usage and Evaluation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2026-07-06 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07349641
The ClinicalTrials.gov registry entry for NCT07349641 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tirzepatide is the first listed.
NCT07349641 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07349641 about?
NCT07349641 is a clinical study titled "A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer". This phase II trial studies whether adding tirzepatide injections to a levonorgestrel intrauterine device (LNG-IUD) improves pathologic response (absence of cancer cells in tissue samples after treatment) in women with endometrial atypical hyperplasia/endometrial intraepithelial neoplasia (AH/EIN) o...
What is the current status of trial NCT07349641?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2026-07-06. Estimated completion is 2029-12-31.
What interventions are being tested in trial NCT07349641?
The interventions under investigation include: Tirzepatide (DRUG), Medical Device Usage and Evaluation (OTHER).
Who is sponsoring clinical trial NCT07349641?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.