Trial · NCT07349641
A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer
NCT07349641, Phase 2, Not yet recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer. Trials, record NCT07349641. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07349641
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer
- NCT number
- NCT07349641
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 55 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia, FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma
- Interventions
- Medical Device Usage and Evaluation, Tirzepatide
- First posted
- 2026-01-20
- Last updated
- 2026-08-26
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weighted pathological complete response (pCR) | At 26 weeks | Proportion of pCR at 26 weeks among patients receiving combined treatment with tirzepatide and levonorgestrel intrauterine device (LNG-IUD) compared to historical controls who received LNG-IUD alone. |
| Secondary | Proportion of participants who achieve pCR on endometrial biopsy | At 52 weeks | Will be compared to historical controls. |
| Secondary | Time to complete response and duration of response | Up to 52 weeks | Will be compared to historical controls. |
| Secondary | Rate of hyperplasia persistence and progression to EC | At 26 and 52 weeks | Will be compared to historical controls as assessed by standard pathologic criteria. |
| Secondary | Percent change in cell proliferation | At baseline and 12, 26, 39, and 52 weeks | Will assess Ki67 within pre-treatment biopsy and post-treatment biopsies. Will also compare with historical controls. |
| Secondary | Percent change in hemoglobin A1C | At baseline and weeks 12, 26, 39, and 52 | Will be measured by means of commercially available assays. |
| Secondary | Percent weight change | Every 4 weeks up to week 20 and at weeks 26, 39, and 52 | Will summarize percent changes from baseline. |
| Secondary | Percent change in fasting blood glucose | Every 4 weeks up to week 20 and at weeks 26, 39, and 52 | Will summarize percent changes from baseline. |
| Other | Change in the endometrial immune microenvironment | At baseline and 12, 26, 39, and 52 weeks | Changes pre- and post-treatment will be assessed. |
| Other | Change in systemic inflammation and metabolic markers | At baseline and 12, 26, 39 and 52 weeks | Will summarize percent changes from baseline. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 | NIH RePORTER |
| UG1CA242609 | iCAN PREVENT: MD Anderson International Cancer Prevention Clinical Trials Consortium | VILAR SANCHEZ, EDUARDO | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 2019 to 2025 | NIH RePORTER |
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07349641
GET https://conductscience.org/api/trials/v1/NCT07349641/registered