Mazdutide Plus LNG-IUS for Fertility-Sparing Treatment of AEH or Early Endometrial Cancer

Sponsor
Tongji Hospital
Study ID
NCT07781150
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Atypical Endometrial Hyperplasia
  • Endometrial Carcinoma Stage I
  • Endometrioid Endometrial Cancer
  • Obesity
  • Overweight

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Mazdutide(Dual GLP-1R/GCGR Agonist) — DRUG
    Mazdutide will be administered by subcutaneous injection once weekly. The starting dose is 2 mg once weekly for weeks 1-4, followed by 4 mg once weekly for weeks 5-8, and 6 mg once weekly from week 9 onward. If 6 mg is not tolerated, the dose may be reduced to 4 mg once weekly according to the protocol.
  • Placebo — DRUG
    Matching placebo will be administered by subcutaneous injection once weekly using the same injection route, frequency, injection volume, appearance, packaging, labeling, injection device, and dose-escalation procedure as mazdutide.
  • Levonorgestrel-releasing intrauterine system — DEVICE
    The levonorgestrel-releasing intrauterine system will be placed in the uterine cavity according to standard clinical practice and will be used as the background fertility-sparing progestin therapy in both treatment groups.

Study Details

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of mazdutide combined with a levonorgestrel-releasing intrauterine system (LNG-IUS) for fertility-sparing treatment in overweight or obese patients with atypical endometrial hyperplasia (AEH) or early-stage endometrioid endometrial cancer. Eligible participants will be randomized in a 1:1 ratio to receive LNG-IUS plus mazdutide or LNG-IUS plus matching placebo. The primary outcome is the complete response rate of endometrial lesions at 24 weeks after randomization.

Key Dates

First listed
Aug 24, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2031

Study Design

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

Arms

  • Experimental: LNG-IUS plus Mazdutide
    Participants will receive LNG-IUS placed in the uterine cavity and mazdutide by subcutaneous injection once weekly using a dose-escalation regimen.
  • Placebo Comparator: LNG-IUS plus Placebo
    Participants will receive LNG-IUS placed in the uterine cavity and matching placebo by subcutaneous injection once weekly using the same dose-escalation schedule as the mazdutide group.

Primary Outcome Measure

Complete response rate of endometrial lesions at 24 week [ Time Frame: At 24 weeks after randomization ]

Central Contacts

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