Trial · Interventional
Not yet recruitingPhase 2Registry dataMazdutide Plus LNG-IUS for Fertility-Sparing Treatment of AEH or Early Endometrial Cancer
Short name MELIA
Overview
- Status
- Not yet recruiting
- Phase
- Phase 2
- Enrollment
- 128 participants (estimated)
- Sponsor
- Tongji Hospital · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
China
- Start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Completion
- 30 Jun 2031 (estimated)
- First posted
- 24 Aug 2026
- Last update posted
- 24 Aug 2026
- Conditions
- Obesity · Overweight · Atypical Endometrial Hyperplasia · Endometrial Carcinoma Stage I · Endometrioid Endometrial Cancer
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Mazdutide(Dual GLP-1R/GCGR Agonist)Drug
- PlaceboDrug
- Levonorgestrel-releasing intrauterine systemDevice
Arms2
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 outcomes1
Outcomes the sponsor listed as primary.
Complete response rate of endometrial lesions at 24 week
Time frame · At 24 weeks after randomization
Registry description
The proportion of participants who achieve complete response of endometrial lesions at the week 24 assessment. Complete response is defined as no residual AEH or endometrioid endometrial cancer on evaluable endometrial pathology obtained by hysteroscopic endometrial biopsy.
Secondary outcomes(20)
Complete response rate at 12 weeks
Time frame · At 12 weeks after randomization
Registry description
The proportion of participants who achieve complete response at the week 12 pathological assessment.
Complete response rate at 36 weeks
Time frame · At 36 weeks after randomization
Registry description
The proportion of participants who achieve complete response at the week 36 pathological assessment.
Time to first complete response
Time frame · From randomization to first documented complete response, up to 36 weeks
Registry description
Time from randomization to the date of the first pathological assessment confirming complete response.
Pathological response status
Time frame · At 12, 24, and 36 weeks after randomization
Registry description
Distribution of pathological response categories, including complete response, partial response, stable disease, progressive disease, and unevaluable specimens.
Fertility-sparing treatment failure and radical surgery
Time frame · From randomization through the end of study follow-up, up to 2 years after complete response
Registry description
Proportion of participants who discontinue fertility-sparing treatment due to disease progression, persistent non-response, intolerance, or other oncologic reasons, and the proportion undergoing radical surgery.
Change in body weight
Time frame · Baseline, 12 weeks, 24 weeks, and 36 weeks after randomization
Registry description
Change from baseline in body weight measured in kilograms.
Percentage change in body weight
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Percentage change from baseline in body weight, calculated as: \[(body weight at visit - baseline body weight) / baseline body weight\] × 100%.
Proportion of participants with at least 5% body weight reduction
Time frame · At 12, 24, and 36 weeks after randomization
Registry description
The proportion of participants with body weight reduction of at least 5% from baseline. The outcome will be reported as a percentage of participants.
Proportion of participants with at least 10% body weight reduction
Time frame · At 12, 24, and 36 weeks after randomization
Registry description
The proportion of participants with body weight reduction of at least 10% from baseline. The outcome will be reported as a percentage of participants.
Change in body mass index
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in body mass index, measured in kg/m\^2.
Change in waist circumference
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in waist circumference, measured in centimeters.
Change in fasting plasma glucose
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in fasting plasma glucose, measured in mmol/L.
Change in HbA1c
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in glycated hemoglobin, measured as percentage.
Change in fasting insulin
Time frame · Baseline, 24 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in fasting insulin, measured in μIU/mL or mIU/L according to the local laboratory standard.
Change in HOMA-IR
Time frame · Baseline, 24 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in homeostatic model assessment of insulin resistance. HOMA-IR is calculated from fasting glucose and fasting insulin and is reported as a unitless index.
Change in total cholesterol
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in total cholesterol, measured in mmol/L.
Change in triglycerides
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in triglycerides, measured in mmol/L.
Change in LDL cholesterol
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in low-density lipoprotein cholesterol, measured in mmol/L.
Change in HDL cholesterol
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in high-density lipoprotein cholesterol, measured in mmol/L.
Change in alanine aminotransferase
Time frame · Baseline, 12 weeks, 24 weeks, 36 weeks, and at early discontinuation of study treatment if applicable
Registry description
Change from baseline in alanine aminotransferase, measured in U/L.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 45 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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