Trial · Interventional

Not yet recruitingPhase 2Registry data

Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer

Short name SWIFT

NCTNCT07820358Other idPRO00043004

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Not yet recruiting
Phase: Phase 2
Enrollment: 48 participants (estimated)
Sponsor: The Methodist Hospital Research Institute · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 1 Jan 2027 (estimated)
Primary completion: 31 Dec 2028 (estimated)
Completion: 31 Dec 2031 (estimated)
First posted: 15 Sept 2026
Last update posted: 1 Oct 2026
Conditions: Endometrial Atypical Hyperplasia · Endometrial Atypical Hyperplasia/Endometrioid Intraepithelial Neoplasia · Endometrial Cancer Stage I · Endometrial Cancer · Fertility-Sparing Treatment (FST) · Obesity & Overweight

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202720282029203020312032

Ph 2
SWIFT
NCT07820358
est. 1 Jan 2027 to est. 31 Dec 2031

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

Semaglutide (Wegovy) weekly injectionDrug
LNG-IUD (Progestin)Device
Structured Weight Loss ProgramBehavioral

Arms1

Experimental
Combination Fertility-Sparing Treatment
Participants will receive a three-component combination intervention consisting of: (1) a levonorgestrel-releasing intrauterine device (LNG-IUD), inserted at baseline; (2) semaglutide 2.4 mg, administered per standard dosing schedule; and (3) a structured weight loss program. Participants will undergo hysteroscopy with endometrial sampling to assess pathological response. Treatment will be administered for 6 months of active intervention, followed by a 6-month follow-up period.

Primary outcomes1

Outcomes the sponsor listed as primary.

Pathological Response Rate
Time frame · 6 months
Registry description
Pathological Response Rate (PRR) defined as the rate of regression of atypical hyperplasia or carcinoma on histopathological examination of the 6-month (end-of-treatment) hysteroscopic sample

Secondary outcomes(5)

Time to response
Time frame · 12 months
Registry description
Time to response in months from treatment initiation to first documented histopathological regression
Adverse events
Time frame · 12 months
Registry description
Incidence and severity of adverse events, graded per NCI-CTCAE v5.0, including drug-related (semaglutide) and device-related (LNG-IUD) events
Durable response rate
Time frame · 12 months
Registry description
The proportion of participants who achieve a complete pathological response and maintain that response, without evidence of disease recurrence or progression, through 12 months following treatment initiation. Durable response will be assessed via hysteroscopy with endometrial sampling.
Disease progression rate
Time frame · 12 months
Registry description
The proportion of participants who experience disease progression, defined as an increase in histologic grade or stage of endometrial atypical hyperplasia or endometrial cancer, without ever achieving a complete pathological response, assessed through 12 months from treatment initiation. Disease status will be assessed via hysteroscopy with endometrial sampling.
Recurrence rate
Time frame · 12 months
Registry description
The proportion of participants who experience recurrence of endometrial atypical hyperplasia or endometrial cancer following an initial complete pathological response, assessed through 12 months from treatment initiation. Disease status will be assessed via hysteroscopy with endometrial sampling.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

10 results

Once-Weekly Semaglutide in Adults with Overweight or Obesity.

Wilding et al. 2021The New England journal of medicinecited by 3,862

PMID 33567185DOI 10.1056/nejmoa2032183PUB-33567185

Full text at the publisher10 results

Publisher page See results (10)

More studies

2 studies on this page

Indexing hint: Animal study · 2024

Tirzepatide as an innovative treatment strategy in a pre-clinical model of obesity-driven endometrial cancer.

Kong et al. 2024Gynecologic oncologycited by 25

PMID 39388742PMC12419173DOI 10.1016/j.ygyno.2024.10.004PUB-39388742

Free to read · publisher termsCC BY-NC-ND

Read at source

PubMed tag: none · 2021

Liraglutide suppresses the proliferation of endometrial cancer cells through the adenosine 5'-monophosphate (AMP)-activated protein kinase signaling pathway.

Zhu et al. 2021Chinese medical journalcited by 17

PMID 33470656PMC7929608DOI 10.1097/cm9.0000000000001363PUB-33470656

Free to read · publisher termsCC BY-NC-ND

Read at source

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Histological Diagnosis: Histologically confirmed endometrial atypical hyperplasia or FIGO grade 1 endometrioid Endometrial Cancer 2. Imaging eligibility (for patients with endometrial cancer): 1. Depth of myometrial invasion \<50% confirmed by MRI or disease limited to the endometrium 2. No evidence of extrauterine or metastatic disease on imaging. 3. Treatment Rationale (at least one of the following must apply): 1. Desire for future fertility: Patient expresses a documented desire to preserve the uterus and future reproductive function, with explicit acknowledgment that fertility-sparing treatment is not standard of care for endometrial cancer. 2. Medical inoperability: patients are considered a poor surgical candidate due to: i. Class III obesity (BMI ≥40 kg/m²); or ii. ASA Physical Status Classification score ≥3. 4. 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). 5. Progestin washout: patients with prior progestin exposure are eligible provided the following minimum washout periods have been observed. 1. Oral progestins: 7 days 2. Injectable, short acting: 14 days 3. Injectable, long acting: 6 months 4. Contraceptive implant: 28 days 5. LNG-IUD: 7 days after removal Exclusion Criteria: 1. Age ≥18 years 2. Negative pregnancy test at screening 3. Ability to provide written informed consent and comply with study procedures 4. Willingness to undergo genetic counseling and MMR/IHC tumor profiling 5. Willingness and ability to participate in a structured weight loss program, including attendance at counseling sessions (in person or virtual) and adherence to dietary and physical activity goals.

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