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Orlistat Plus Progestin for Fertility-Sparing Treatment of Endometrial Cancer or Atypical Hyperplasia

NCT07714070 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-07-20

No results posted yet for this study

Summary

This is a single-center, randomized, open-label, controlled clinical trial evaluating whether adding orlistat to standard progestin therapy can improve treatment response in patients receiving fertility-sparing treatment for early-stage endometrial cancer (grade 1-2) or atypical endometrial hyperplasia.

Progestin is the standard drug used to preserve the uterus and fertility in these patients, but about 30% of patients respond poorly because the progesterone receptor (PR) in the endometrium is lost or reduced. Laboratory studies by the research team have shown that orlistat, a widely used oral weight-loss drug that blocks fat absorption, can raise PR levels and restore sensitivity to progestin.

The study will enroll 48 patients (age 45 years or younger, body mass index 24 kg/m2 or higher) who still have residual disease and low PR expression after at least 3 months of first-line progestin therapy. Participants will be randomly assigned in a 1:1 ratio to receive either progestin plus orlistat (experimental group) or progestin alone (control group) for 3 months, followed by 24 months of follow-up. The main goal is to compare the change in PR expression from baseline after 3 months of treatment. The study will also assess how many patients achieve complete disease reversal, time to complete response, recurrence, pregnancy and live-birth rates, safety, and changes in body weight and metabolic measures.

Conditions

  • Endometrial Neoplasms
  • Endometrial Cancer
  • Atypical Endometrial Hyperplasia
  • Progestin Resistance

Interventions

DRUG

Orlistat

Oral orlistat 120 mg three times daily, taken with meals or within 1 hour after a meal, for 3 months. A dose may be omitted if a meal is skipped or contains no fat.

DRUG

Progestin

High-potency progestin given orally as background therapy in both groups: medroxyprogesterone acetate 250-500 mg/day or megestrol acetate 160-320 mg/day, with the specific agent and dose individualized by the investigator based on body weight, liver function, and prior dose.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2027-09-30
Completion
2029-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07714070 on ClinicalTrials.gov