GLP-1 Evidence

Not medical advice. A record of published research and our assessments of it. The limits

SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer

SHAPE-ENDO (Strategic Hormonal Approach & Prehabilitation in Endometrial Cancer): An Open-Label, Pilot Randomized Clinical Trial Comparing Standard Immediate Surgery Versus a Multimodal Metabolic Optimization and Prehabilitation Strategy Before Surgery in Patients With Atypical Endometrial Hyperplasia or Low-Risk Endometrioid Endometrial Cancer and BMI ≥40 kg/m²
NCT07462663 on ClinicalTrials.gov

Status
Not yet recruitingResults none
Why it is watched
non-weight indication: cancer
Who it enrolls
age 18 Years to no upper limit; female; no BMI minimum stated; conditions: Endometrial Cancer; Endometrial Cancer Stage I; Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I; Atypical Endometrial Hyperplasia
Interventions
GLP-1 Receptor Agonist; Levonorgestrel IUD (Lng-IUD); Oral Progestins; Dietetic-Nutritional intervention; Structured Exercise and Prehabilitation Program; Endometrial Biopsy With or Without Hysteroscopy; Radiologic Surveillance (MRI and Transvaginal Ultrasound); Standar upfront Surgery
Conditions
Endometrial Cancer; Endometrial Cancer Stage I; Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I; Atypical Endometrial Hyperplasia; Endometrial Intraepithelial Neoplasia; Obesity & Overweight; BMI>40; Obesity; Obesity Grade III
Phase and size
Phase 4 · 80 participants
Dates
Start 2027-01
Primary completion 2031-04
Sponsor
Hospital Universitari de Bellvitge (Other)
Last checked
Sep 13, 2026
01Endpoints

What the trial will measure

  • Recruitment RateFrom study opening to end of recruitment, up to 36 months.
  • Acceptance of Randomization RateAt baseline, before randomization.
  • Participant Retention RateFrom randomization to surgery and 30 days postoperatively, up to 14 months.
  • Adherence to the Assigned InterventionFrom randomization to surgery and 30 days postoperatively, up to 14 months.
  • Completion of the SHAPE-ENDO Multimodal StrategyFrom randomization to week 28 or week 54.
  • Proportion of SHAPE-ENDO Participants Reaching Surgery Without Tumor ProgressionFrom randomization to surgery, up to 54 weeks.
  • Incidence of Serious Adverse Events, Tumor Progression, and Study DiscontinuationFrom randomization to surgery and 30 days postoperatively, up to 14 months.
02Eligibility

Who can take part

Inclusion Criteria: * Female participants ≥18 years old. * Histologically confirmed atypical endometrial hyperplasia/endometrial intraepithelial neoplasia (AEH/EIN) or low-risk endometrioid endometrial carcinoma, grade 1 or 2. * Disease apparently confined to the uterine corpus, assessed by expert transvaginal ultrasound and/or pelvic magnetic resonance imaging. * Low- or intermediate-risk disease according to ESGO-ESTRO-ESP 2025 criteria, including presurgical stages IA1, IA2, or IB. * Negative or focal lymphovascular space invasion, if available. * Favorable molecular profile, if available, including POLE-mutated, p53 wild-type, MMR-deficient, or NSMP estrogen receptor-positive disease. * Body mass index ≥40 kg/m² at inclusion. * Considered a candidate for surgical treatment by the multidisciplinary tumor board. * Ability to understand and sign written informed consent after receiving oral and written information about the study, including acceptance of random assignment to either standard immediate surgery or the SHAPE-ENDO multimodal pre-surgical optimization strategy. Exclusion Criteria: * FIGO stage IA3, IC, II, or higher disease. * Extensive lymphovascular space invasion, if available. * High-risk molecular profile, including p53-abnormal/mutated disease or NSMP estrogen receptor-negative disease. * Non-endometrioid histology, including serous carcinoma, clear-cell carcinoma, carcinosarcoma, mixed histology, or other high-risk histological subtypes. * Metastatic disease or suspicion of extrauterine disease. * Considered medically inoperable or "unfit" for surgery because of severe comorbidity, frailty, anesthetic contraindication, or any other clinical reason contraindicating surgical treatment. * Contraindication to GLP-1 receptor agonist therapy or progestin-based hormonal therapy, including levonorgestrel-releasing intrauterine device or oral progestins. * Previous pancreatitis, medullary thyroid carcinoma, or multiple endocrine neoplasia type 2. * Concurrent participation in another interventional pharmacological clinical trial. * Any condition that, in the investigator's judgment, may compromise participant safety, interfere with protocol compliance, or make participation inappropriate.
03Change log

Registry changes

No changes recorded since the trial was added.