GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2, PHASE3

Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia

A Randomized Controlled Pilot Study of Polyethylene Glycol Loxenatide Plus LNG-IUS in Women With Endometrial Atypical Hyperplasia

Lead sponsor

Fudan University

Asset

Loxenatide / PEG-loxenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, Oncology, Reproductive / infertility

Key I/E criteria

•BMI ≥28•Female

Primary endpoint

•Pathological complete response (CR) rates

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05172999

Org study ID53211033

Timeline

Milestones

Study first posted2021-12-29actual

Study start2022-01-08actual

Primary completion2025-12-30actual

Study completion2026-02-28actual

Last update posted2026-03-13actual

Assets

Investigational agents

Loxenatide / PEG-loxenatide

Study populations

Who this study enrolls

Obesity / overweightOncologyReproductive / infertility

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexFemale

Healthy volunteersNot accepted

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

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Other clinical outcomes

Weight & body composition

1 endpoint

Secondary/protocol endpoint

weight change

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

descriptive

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

changing of insulin resistance

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

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

safety and side effects

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

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Relapse rates

Time frame:up to 2 years after the treatment for each patient

descriptive

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Pathological complete response (CR) rates

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

descriptive

Secondary/protocol endpoint/low confidence

16-week complete response (CR) rates

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

descriptive

Secondary/protocol endpoint/low confidence

28-week complete response (CR) rates

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

descriptive

Secondary/protocol endpoint/low confidence

Time of pathological complete response (CR)

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

descriptive

Secondary/protocol endpoint/low confidence

pregnancy outcomes

Time frame:up to 2 years after the treatment for each patient

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.