LNG-IUD + Semaglutide for Endometrial Cancer

(SWIFT Trial)

Not yet recruiting at 3 trial locations
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: The Methodist Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if a combination treatment of a hormonal intrauterine device (LNG-IUD), semaglutide, and a structured weight loss program can treat endometrial atypical hyperplasia or grade 1 endometrioid endometrial cancer while preserving fertility in women of reproductive age with endometrial atypical hyperplasia (EAH) or FIGO grade 1 endometrioid endometrial cancer who wish to preserve their fertility. The main questions it aims to answer are:

* What proportion of participants achieve a complete pathological response after treatment?

* How durable is the response at 12 months?

* What effect does the treatment have on metabolic outcomes (weight, BMI, HbA1c) and quality of life?

Participants will:

* Receive an LNG-IUD

* Receive semaglutide 2.4mg

* Participate in a structured weight loss program

* Undergo hysteroscopy with endometrial sampling to assess treatment response

* Complete quality-of-life assessments at baseline, 6 months, and 12 months

Who Is on the Research Team?

AA

Aparna A. Kamat, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for women of reproductive age who have endometrial atypical hyperplasia or early-stage (grade 1) endometrial cancer and want to keep their ability to have children. Participants should also be overweight or obese.

Inclusion Criteria

Metabolic profile: BMI ≥ 30 kg/m², or BMI 27-29.9 kg/m² with at least one weight-related comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease)
Treatment rationale: Medical inoperability due to Class III obesity (BMI ≥40 kg/m²) or ASA Physical Status Classification score ≥3
I have been diagnosed with early-stage endometrial cancer or atypical hyperplasia.
See 4 more

Exclusion Criteria

Positive pregnancy test at screening
I am under 18 years old.
Inability to provide written informed consent or comply with study procedures
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • LNG-IUD
  • Semaglutide
  • Structured Weight Loss Program

Trial Overview

The study tests a combination of three treatments: a hormonal IUD (LNG-IUD), weekly semaglutide injections, and a structured weight loss program. The goal is to see if this approach can treat the condition while preserving fertility.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Combination Fertility-Sparing TreatmentExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+