GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 2

A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia

A Pilot Study to Estimate Early Clinical Efficacy Signals of a Glucagon-like Peptide 1 Receptor Agonist (GLP-1RA) Administration in Conjunction With Levonorgestrel Intrauterine Device (LNG-IUD) in Obese Patients With Endometrioid Intraepithelial Neoplasia

Lead sponsor

University of Florida

Assets

GLP-1 / incretin class catch-all / Liraglutide / Semaglutide / Tirzepatide

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Oncology

Key I/E criteria

•BMI ≥30•Female

Primary endpoints

•Time from start of GLP-1RA to clearance of staging hysterectomy•Time from start of GLP-1RA to clearance for pregnancy pursuit•Endometrial pathologic response

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 IDNCT07107334

Org study IDUF-GYN-003

Timeline

Milestones

Study first posted2025-08-06actual

Study start2026-04-07actual

Last update posted2026-04-09actual

Primary completion2028-11estimated (month precision)

Study completion2029-11estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide Semaglutide Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightOncology

Eligibility

Who can enroll

Minimum age18 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Adults ≥ 18 years old

•A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN

•For subjects with a diagnosis of endometrial intraepithelial neoplasia/grade 1 endometrioid endometrial adenocarcinoma prior to enrollment in the study, and with a diagnosis made outside this institution, the diagnostic material originating from outside the study site will undergo in-house pathology review before enrollment acceptance.

•ECOG Performance Status of 0 to 3

•For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound

•BMI ≥ 30 kg/m2 and one of the following (per medical record or self-report):

1. Multiple medical co-morbidities (defined as American Society of Anesthesiologists [ASA] score ≥ 3) at physician discretion

2. Fertility desire

•Subject has had appropriate age-related breast examinations and imagining prior to study enrollment, as documented in the medical record or via investigator confirmation.

•Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.

Exclusion criteria

•Subjects with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous)

•Clinical suspicion of metastatic disease as assessed by the treating physician or confirmed metastatic disease based on imaging

•Subjects with abnormal cervical cytology

•Subjects who are diagnosed with thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2

•Subjects who are confirmed to be pregnant or breastfeeding

•History of medullary thyroid cancer

•Subjects with known current or history of hormonally- sensitive carcinoma (e.g., breast, melanoma)

•Subjects actively taking GLP-1RA for more than 14 days at time of consent.

•Subjects with levonorgestrel-releasing intrauterine system placed >45 days prior to study enrollment.

•Subjects must not have more than one active malignancy at the time of enrollment (Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with safety or efficacy assessment of the study [as determined by the treating physician or approved by the PI] may be included).

•History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. This includes, but is not limited to, conditions such as New York Heart Association (NYHA) Class IV heart failure.

•Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Endpoints (10)

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 clinical outcomes

Patient-reported / QoL

3 endpoints

Secondary/protocol endpoint

Patient-reported quality of life

Time frame:6 months

change from baseline, improvement

Secondary/protocol endpoint

Patient-reported quality of life

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Patient-reported quality of life

Time frame:at either clearance for pregnancy pursuit or staging hysterectomy, which will ideally occur by 12 months after beginning study treatment

change from baseline, improvement

Other clinical outcomes

7 endpoints

Primary/protocol endpoint

Time from start of GLP-1RA to clearance of staging hysterectomy

Time frame:12 months

time to event, improvement

Primary/protocol endpoint

Time from start of GLP-1RA to clearance for pregnancy pursuit

Time frame:12 months

time to event, event

Primary/protocol endpoint

Endometrial pathologic response

Time frame:6 months after beginning GLP-1RA treatment

categorical status, improvement

Primary/protocol endpoint

Endometrial pathologic response

Time frame:12 months after beginning GLP-1RA treatment

categorical status, improvement

Secondary/protocol endpoint

Length of surgery

Time frame:Intraoperative

descriptive

Secondary/protocol endpoint

Number of nights in hospital

Time frame:12 months

event count, descriptive

Secondary/protocol endpoint

Postoperative complications

Time frame:12 months

event count, event

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.