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

Sponsor
Peking University People's Hospital
Study ID
NCT07714070
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
N/A - 46 Years
Healthy Volunteers
Not accepted

Interventions

  • Orlistat — DRUG
    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.
  • Progestin — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 20, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Orlistat Plus Progestin
    Participants receive high-potency progestin (medroxyprogesterone acetate 250-500 mg/day or megestrol acetate 160-320 mg/day, dose individualized by the investigator) combined with oral orlistat 120 mg three times daily, taken with meals or within 1 hour after a meal, for 3 months.
  • Active Comparator: Progestin Alone
    Participants receive high-potency progestin alone (medroxyprogesterone acetate 250-500 mg/day or megestrol acetate 160-320 mg/day, dose individualized by the investigator) for 3 months.

Primary Outcome Measure

Relative change in progesterone receptor (PR) expression from baseline at 3 months (delta PR%) [ Time Frame: Baseline and 3 months (90 +/- 7 days after randomization) ]

Central Contacts

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