Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia

NCT05172999 | Completed Phase 2 DMC

• 1 other identifier: 53211033
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To study if polyethylene glycol loxenatide plus levonorgestrel-releasing intrauterine system (LNG-IUS) will improve response rates in patients with endometrial atypical hyperplasia.

Conditions

Atypical Endometrial Hyperplasia; Obesity; Fertility Issues

Keywords

atypical endometrial hyperplasia, obesity, fertility

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (CR) rates

  The 32-week CR rates will be calculated in two groups

  From date of randomization until the date of CR, assessed up to 32 weeks.

Secondary Outcomes (8)

• 16-week complete response (CR) rates

  From date of randomization until the date of CR, assessed up to 16 weeks.

• 28-week complete response (CR) rates

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

• weight change

  From date of randomization until the date of CR, assessed up to 32weeks.

• changing of insulin resistance

  From date of randomization until the date of CR, assessed up to 32weeks.

• Time of pathological complete response (CR)

  From date of randomization until the date of CR, assessed up to 2 years

Study Arms (2)

LNG-IUS

ACTIVE COMPARATOR

enrolled patients will receive LNG-IUS for 6 months or longer till complete response

Device: levonorgestrel-releasing intrauterine system

LOX+LNG-IUS

EXPERIMENTAL

enrolled patients will receive LNG-IUS plus polyethylene glycol loxenatide for treatment.

Device: levonorgestrel-releasing intrauterine system; Drug: Polyethylene Glycol Loxenatide

Interventions

levonorgestrel-releasing intrauterine system DEVICE

Enrolled patients will be inserted this device for treating AEH to preserve fertility for 3-6 months or longer till complete response or operation if treatment fails, and the device may be removed if treatment changes.

Also known as: MIRENA

LNG-IUS; LOX+LNG-IUS

Polyethylene Glycol Loxenatide DRUG

Initiate injection of Loxenatide will be 0.1mg per week, if the patient can tolerate, the dose will be increased to 0.2mg per week, or else 0.1mg per week will be injected and the injection will last for no more than 28 weeks. If the patient cannot tolerate the least 0.1mg/week, she must be excluded from this trial.

Also known as: Fulaimei, PEX168

LOX+LNG-IUS

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known or suspected pregnancy
• Currently suffering from pelvic inflammatory disease or diagnosed as pelvic inflammatory disease
• Lower reproductive system infection
• abnormal cervical dysplasia
• Congenital or acquired uterine abnormalities, including fibroids that deform the uterine cavity
• Allergic to any parts of LNG-IUS components
• The uterine cavity is too large (average diameter is over 7cm) or the history of LNG-IUS falling off

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

Location

MeSH Terms

Conditions

Endometrial Hyperplasia; Obesity; Infertility

Interventions

polyethylene glycol loxenatide

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• XIAOJUN CHEN, PhD

  Obstetrics & Gynecology Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator，Clinical Professor

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 29, 2021
• Study Start: January 8, 2022
• Primary Completion: December 30, 2025
• Study Completion: February 28, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CN (1)