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New combo therapy shows promise for uterine condition in obese women

NCT ID NCT05172999

Disease control Sponsor: Fudan University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a diabetes drug (polyethylene glycol loxenatide) to a hormone-releasing IUD (LNG-IUS) helps women with a precancerous uterine condition called endometrial atypical hyperplasia. The 30 participants were all obese and wanted to preserve their fertility or keep their uterus. The goal was to see if the combination led to a complete disappearance of abnormal cells within 32 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

30 people

The number who actually took part.

Started

Jan 2022

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

atypical endometrial hyperplasia Endometrial Hyperplasia infertility disorder Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atypical endometrial hyperplasia Fertility issues Obesity

Contacts and locations

Locations

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200090, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.