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

What Was Tested

This registered phase 4 trial tested Semaglutide for endometriosis and hyperparathyroidism.

The study will evaluate the feasibility, safety, and acceptability of comparing two treatment strategies in women with atypical endometrial hyperplasia/endometrial intraepithelial neoplasia or low-risk endometrioid endometrial cancer and grade III obesity, defined as BMI ≥40 kg/m².

Eligible participants will be randomized in a 1:1 ratio to one of two arms.

It had two arms (groups): Arm A - Standard Immediate Surgery (active comparator) and Arm B - Experimental: SHAPE-ENDO Multimodal Strategy Before Surgery (experimental).

The registry classes the interventions as behavioral, device, drug and procedure.

More on the Plan

Although surgery remains the standard treatment for atypical endometrial hyperplasia and early-stage endometrioid endometrial cancer, patients with grade III obesity may experience a higher risk of perioperative complications.

The SHAPE-ENDO strategy combines semaglutide-based metabolic optimization, local hormonal therapy with a levonorgestrel-releasing intrauterine device with or without oral progestins, structured nutritional support, adapted physical exercise, and scheduled histologic and radiologic monitoring.

This pilot randomized trial will compare standard immediate surgery with the SHAPE-ENDO multimodal pre-surgical optimization strategy.

Participants in both arms will undergo long-term clinical and oncologic follow-up for at least 5 years after randomization.

Who Took Part

80 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the endometriosis participants stayed in one arm throughout.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2027-01 with completion listed for 2031-04.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Recruitment Rate (time frame: From study opening to end of recruitment, up to 36 months). Acceptance of Randomization Rate (time frame: At baseline, before randomization). Participant Retention Rate (time frame: From randomization to surgery and 30 days postoperatively, up to 14 months).

It also tracked 27 secondary outcomes, for example Perioperative Morbidity, Surgical Approach, Conversion to Laparotomy, Operative Time, Estimated Blood Loss and Need for Blood Transfusion.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 80 people with endometriosis.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, Endometriosis research, Hyperparathyroidism research.