WithdrawnPhase 2, PHASE3

Liraglutide Plus Megestrol Acetate in Endometrial Atypical Hyperplasia

Megestrol Acetate Versus Liraglutide Plus Megestrol Acetate in Obese Women with Endometrial Atypical Hyperplasia: a Randomized Controlled Pilot Clinical Study

Lead sponsor

Xiaojun Chen

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Obesity / overweight, Oncology, Reproductive / infertility

Eligibility highlights

•BMI ≥28•Female

Primary endpoint

•Pathological complete response (CR) rates

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 IDNCT04683237

Org study ID53211031

Timeline

Milestones

Study first posted2020-12-24actual

Study start2021-03-20actual

Last update posted2024-09-26actual

Primary completion2025-11-30estimated

Study completion2026-11-30estimated

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweightOncologyReproductive / infertility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•BMI (body mass index) ≥28kg/m2

•Consent informed and signed

•Pathologically confirmed as endometrial atypical hyperplasia

•Have a strong desire to reproduce and ask for fertility preservation or those who insist on keeping the uterus despite no reproductive requirements

•Have good compliance and follow-up conditions, and patients are willing to follow up in Obstetrics and Gynecology Hospital of Fudan University in time

Exclusion criteria

•Diagnosed as type 2 diabetes

•Diabetic ketoacidosis

•History of acute pancreatitis

•Have a history or family history of medullary thyroid carcinoma; multiple endocrine neoplasia syndrome type 2 (MEN2)

•Combined with severe medical disease or severely impaired liver and kidney function

•Patients with other types of endometrial cancer or other malignant tumors of the reproductive system; patients with breast cancer or other hormone-dependent tumors that cannot be used with progesterone

•Those who require hysterectomy or other methods other than conservative treatment with drugs

•Deep vein thrombosis, stroke, myocardial infarction

•Smokers (≥15 cigarettes/day)

Endpoints (8)

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

Other clinical outcomes

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint

weight lose

Time frame:From date of randomization until the date of CR, assessed up to 28 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

changing of insulin resistance

Time frame:From date of randomization until the date of CR, assessed up to 28 weeks.

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

safety and side effects

Time frame:From date of randomization until the date of CR, assessed up to 2 years.

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

Pathological complete response (CR) rates

Time frame:From date of randomization until the date of CR, assessed up to 28 weeks.

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

Time of pathological complete response (CR)

Time frame:From date of randomization until the date of CR, assessed up to 2 years.

time to event, improvement

Secondary/protocol endpoint/low confidence

Relapse rates

Time frame:up to 2 years after the treatment for each patient

event count, event

Secondary/protocol endpoint/low confidence

pregnancy outcomes

Time frame:up to 2 years after the treatment for each patient

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

improvement of chronic inflammation

Time frame:From date of randomization until the date of CR, assessed up to 28 weeks

change from baseline, improvement

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.