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

9 september 2026 bijgewerkt door: Aparna A. Kamat, The Methodist Hospital Research Institute

SEMAGLUTIDE, WEIGHT LOSS, AND INTRAUTERINE THERAPY FOR FERTILITY-SPARING AND CONSERVATIVE TREATMENT FOR ENDOMETRIAL ATYPICAL HYPERPLASIA AND EARLY-STAGE, GRADE 1 ENDOMETRIOID ENDOMETRIAL CANCER

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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

48

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Texas
      • Houston, Texas, Verenigde Staten, 77030
      • Houston, Texas, Verenigde Staten, 77030
      • Houston, Texas, Verenigde Staten, 77030
      • Houston, Texas, Verenigde Staten, 77030

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Geneesmiddel: Semaglutide (Wegovy) weekly injection
Semaglutide 2.4 mg administered subcutaneously once weekly, following standard dose-escalation protocol, for the duration of the 6-month active treatment period. Used off-label in this trial for its metabolic effects in combination with LNG-IUD, rather than as monotherapy for weight loss.
Apparaat: LNG-IUD (Progestin)
Levonorgestrel-releasing intrauterine device inserted at study baseline and maintained through the active treatment and follow-up periods, providing continuous local progestin delivery to the endometrium in combination with systemic semaglutide.
Gedragsmatig: Structured Weight Loss Program
A structured, protocol-defined weight loss program combining dietary counseling and physical activity guidance, delivered concurrently with pharmacologic and device-based treatment to support metabolic response, distinct from weight loss achieved through semaglutide alone.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pathological Response Rate
Tijdsspanne: 6 months
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
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to response
Tijdsspanne: 12 months
Time to response in months from treatment initiation to first documented histopathological regression
12 months
Adverse events
Tijdsspanne: 12 months
Incidence and severity of adverse events, graded per NCI-CTCAE v5.0, including drug-related (semaglutide) and device-related (LNG-IUD) events
12 months
Durable response rate
Tijdsspanne: 12 months
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.
12 months
Disease progression rate
Tijdsspanne: 12 months
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.
12 months
Recurrence rate
Tijdsspanne: 12 months
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.
12 months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body weight change
Tijdsspanne: 12 months
Change in body weight, measured in kilograms, from baseline to 6 and 12 months following treatment initiation.
12 months
Body mass index (BMI) change
Tijdsspanne: 12 months
Change in body mass index (BMI), calculated as weight in kilograms divided by height in meters squared, from baseline to 6 and 12 months following treatment initiation.
12 months
Waist circumference change
Tijdsspanne: 12 months
Change in waist circumference, measured in centimeters, from baseline to 6 and 12 months following treatment initiation.
12 months
Hip circumference change
Tijdsspanne: 12 months
Change in hip circumference, measured in centimeters, from baseline to 6 and 12 months following treatment initiation.
12 months
Waist-to-hip ratio change
Tijdsspanne: 12 months
Change in waist-to-hip ratio, calculated as waist circumference divided by hip circumference, from baseline to 6 and 12 months following treatment initiation.
12 months
Glycated Hemoglobin change
Tijdsspanne: 12 months
Change in glycated hemoglobin (HbA1c), measured as a percentage, from baseline to 6 and 12 months following treatment initiation.
12 months
Weight-Related Quality of Life (WRQOL)
Tijdsspanne: 12 months
Change in weight-related quality of life, assessed using a validated WRQOL questionnaire, from baseline to 6 and 12 months following treatment initiation.
12 months
Health-Related Quality of Life (HRQOL)
Tijdsspanne: 12 months
Change in health-related quality of life, assessed using a validated HRQOL questionnaire, from baseline to 6 and 12 months following treatment initiation.
12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

The Methodist Hospital Research Institute

Onderzoekers

  • Hoofdonderzoeker: Aparna A. Kamat, MD, The Methodist Hospital Research Institute

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

31 december 2028

Studie voltooiing (Geschat)

31 december 2031

Studieregistratiedata

Eerst ingediend

9 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 september 2026

Eerst geplaatst (Werkelijk)

15 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 september 2026

Laatste update ingediend die voldeed aan QC-criteria

9 september 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PRO00043004

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified individual participant data, including the study protocol and statistical analysis plan, will be made available to researchers who provide a methodologically sound proposal, beginning 12 months after publication of the primary results and ending 36 months after publication. Data will be shared for the purpose of achieving the aims outlined in the approved proposal, following execution of a data access agreement.

IPD-tijdsbestek voor delen

Data will become available beginning 12 months after publication of the primary study results and will remain available for 36 months thereafter.

IPD-toegangscriteria voor delen

De-identified individual participant data, including the study protocol, statistical analysis plan, and informed consent form, will be available to researchers who provide a scientifically sound proposal for data use. Requests should be directed to the principal investigator. Proposals will be reviewed to confirm that the intended use is consistent with the original trial objectives and applicable data protection regulations. Approved requesters will be required to sign a data access agreement prior to receiving data. Access will be granted for the purpose of achieving the aims outlined in the approved proposal.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Ja

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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