Tirzepatide in Endometrioid intraepithelial neoplasia: NCT07349641 Clinical Landscape Report 2026

18 September 2026
9 min read

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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.

Data snapshot: 18 September 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.

Phase 2

Clinical phase

Not yet recruiting

Recruitment status

55

Planned enrollment

2029-10-31

Primary-completion proxy

Executive view

NCT07349641 evaluates Tirzepatide in Endometrioid intraepithelial neoplasia. The disclosed sponsor is National Cancer Institute, the design is Interventional, and the geographic footprint is United States. The first listed primary endpoint is Weighted pathological complete response (pCR), assessed over At 26 weeks.

The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.

PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.

How the MCP evidence stack was assembled

Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT07349641 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Endometrioid intraepithelial neoplasia landscape. Drug & Asset MCP drug_fetch was queried for Tirzepatide, while Company & Deal Intelligence MCP organization_fetch was queried for National Cancer Institute.

This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.

Trial landscape table

TrialAsset / interventionPhase / statusSponsorGeographyPrimary endpointReadout proxy
NCT07349641TirzepatidePhase 2 / Not yet recruitingNational Cancer InstituteUnited StatesWeighted pathological complete response (pCR)
At 26 weeks
2029-10-31
NCT07470853HWK-016Phase 1 / RecruitingWhitehawk Therapeutics, Inc.United StatesDetermine Maximum Tolerated Dose (MTD)
From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles)
2028-02-01
NCT07462663GLP-1 agonist (Nxera Pharma)Phase 4 / Not yet recruitingBellvitge University HospitalGeography not reportedRecruitment Rate
From study opening to end of recruitment, up to 36 months.
2031-04-01
NCT07453394OlaparibPhase 1/2 / Not yet recruitingQilu Pharmaceutical Co., Ltd.Geography not reportedIncidence and severity of adverse events
up to 2 years
2027-04-01
NCT07444814HWK-007Phase 1 / RecruitingWhitehawk Therapeutics, Inc.United StatesDetermine Maximum Tolerated Dose (MTD)
From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
2028-10-01

The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.

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Protocol design and endpoint interpretation

NCT07349641 is a Phase 2, not yet recruiting study with 55 planned participants. Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment.

The primary endpoint is “Weighted pathological complete response (pCR)” over “At 26 weeks.” The retrieved endpoint description is: 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..

Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of 55 should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.

No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.

Indexed readouts in the surrounding landscape

5 recent result records were selected as contextual evidence for Endometrioid intraepithelial neoplasia. These records do not establish direct evidence for NCT07349641 unless the registration number matches.

A Phase 1b/2, Open-Label, Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab for Participants With Advanced Unresectable and/or Metastatic Immune Checkpoint Inhib…

Phase 1/2; n=97; Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 = 62 Participants ; Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE v5.0 = 3 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05572684

A Phase II, Single-Arm Study of RAD001 (Everolimus), Letrozole, and Metformin in Patients With Advanced or Recurrent Endometrial Carcinoma

Phase 2; n=62; CBR = 27 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT01797523

A Phase Ib/II Open Label, Multi-arm, Parallel Cohort Dose Finding and Expansion Study to Assess the Safety, Pharmacokinetics and Efficacy of NUC-3373, a Nucleotide Analogue, Given…

Phase 1/2; n=19; Number of Participants With DLTs in Each Module = 0 Participants ; Number of Participants With DLTs in Each Module = 0 Participants Source: https://clinicaltrials.gov/ct2/show/results/NCT05714553

Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.

Asset and sponsor context

Tirzepatide is indexed as Synthetic peptide with GIPR x GLP-1R biology and a global stage of Approved. The asset profile lists Lexaria Bioscience Corp. as an originator or developer.

National Cancer Institute is indexed in United States with the website http://www.cancer.gov. The National Cancer Institute (NCI) is part of the National Institutes of Health (NIH), which is one of eleven agencies. The record lists 205 development-stage drug assets.

For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.

Development white space

  1. Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
  2. Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
  3. Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
  4. Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
  5. Sequencing white space. Clarify whether Tirzepatide is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.

White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.

Strategic implications and next readouts

For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.

For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.

Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.

Source trail and bottom line

Anchor trial: NCT07349641
Protocol source: https://clinicaltrials.gov/study/NCT07349641
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 18 September 2026.

Tirzepatide in Endometrioid intraepithelial neoplasia is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Weighted pathological complete response (pCR) and 2029-10-31 the leading decision points.

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