WithdrawnPhase 2

Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

Lead sponsor

Washington University School of Medicine

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Oncology

Eligibility highlights

•BMI ≥30•Female

Primary endpoint

•Endometrial hyperplasia free biopsy with uterine preservation

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05829460

Org study ID202402083

Timeline

Milestones

Study first posted2023-04-25actual

Study start2025-03-12actual

Last update posted2026-01-12actual

Primary completion2030-04-30estimated

Study completion2032-04-30estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightOncology

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of histologically confirmed non-atypical endometrial hyperplasia (EH) or complex atypical endometrial hyperplasia (AEH).

-Patients with a previous diagnosis of EH or AEH who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible provided they have not previously been on a GLP-1R agonist within 3 months prior to enrollment.

-For patients with a previous diagnosis of EH or AEH who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be less than or equal to 6 months.

•Premenopausal woman with a uterus.

•At least 18 years of age and no more than 45 years of age.

•Interested in uterine preservation/fertility-sparing treatment.

•BMI ≥ 30 kg/m2.

•Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.

•Prior or current receipt of metformin is allowed.

•Ability to understand and willingness to sign an IRB approved written informed consent document.

Exclusion criteria

•Prior use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide or any DPP-4 inhibitor in the 3 months prior to date of registration.

•History of type 1 diabetes.

•History of type 2 diabetes requiring use of insulin.

•Acute decompensation of glycemic control.

•Concomitant use of other weight management drugs or drugs for short-term weight loss.

•History of surgery or use of a device to treat obesity.

•Uncontrolled thyroid disease

•Acute coronary or cerebrovascular event in the previous 60 days.

•Currently planned coronary, carotid, or peripheral artery revascularization.

•Chronic heart failure (NYHA class IV).

•Evidence of renal dysfunction as defined by creatinine clearance < 60 ml/minute.

•History of solid organ transplant or awaiting solid organ transplant.

•Diagnosis of any malignant neoplasm or current, active treatment with chemotherapy or radiation.

•Family or personal history of multiple endocrine neoplasia syndrome type 2 (MEN 2) or familial medullary thyroid carcinoma (MTC).

•A history of allergic reactions attributed to compounds of similar chemical or biologic composition to progestin, semaglutide, or other agents used in the study.

•History of diabetic retinopathy.

•Recent history of pancreatitis, defined as less than 6 months prior to enrollment.

•History of suicidal attempts or active suicidal ideation.

•Significant active psychiatric disease, including recent psychiatric inpatient admission or use of any psychiatric medications that are not stabilized.

•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.

•Pregnant and/or breastfeeding. Participants must have a negative serum pregnancy test within 7 days of date of registration.

•Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL, they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration, or they are receiving anti-retrovirals that affect progestin levels. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Other clinical outcomes

Weight & body composition

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in weight

Time frame:From baseline to 2 years

Body weight, absolute change (kg)

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change in Cancer Worry Impact of Events Scale (CWIES)

Time frame:At enrollment, 12 months, and end of treatment (estimated to be 2 years)

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life (IWQOL-Lite)

Time frame:At enrollment, 12 months, and end of treatment (estimated to be 2 years)

IWQOL-Lite total

change from baseline, improvement

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Number of patients with endometrial hyperplasia free biopsy with uterine preservation

Time frame:At 2 years (or exit from study)

categorical status, improvement

Secondary/protocol endpoint

Time to resolution of endometrial hyperplasia (EH)

Time frame:Through completion of follow-up (estimated to be 4 years)

time to event, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Hyperplasia-free survival

Time frame:Through completion of follow-up (estimated to be 4 years)

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.