Trial · NCT07349641
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| 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. |
| Other | Weight-independent effects of glucagon-like peptide 1 on cell proliferation (Ki-67+) | At baseline and 12, 26, 39 and 52 weeks | |
| Other | Effect of intervention on treatment response | At 26 and 52 weeks | Will evaluate the effect of the intervention (combined treatment of tirzepatide and levonorgestrel intrauterine device) on treatment response. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT07349641/registered