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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 oppdatert av: 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

48

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Texas
      • Houston, Texas, Forente stater, 77030
      • Houston, Texas, Forente stater, 77030
      • Houston, Texas, Forente stater, 77030
      • Houston, Texas, Forente stater, 77030

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: 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.
Enhet: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pathological Response Rate
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to response
Tidsramme: 12 months
Time to response in months from treatment initiation to first documented histopathological regression
12 months
Adverse events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Body weight change
Tidsramme: 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
Tidsramme: 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
Tidsramme: 12 months
Change in waist circumference, measured in centimeters, from baseline to 6 and 12 months following treatment initiation.
12 months
Hip circumference change
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Methodist Hospital Research Institute

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. januar 2027

Primær fullføring (Antatt)

31. desember 2028

Studiet fullført (Antatt)

31. desember 2031

Datoer for studieregistrering

Først innsendt

9. september 2026

Først innsendt som oppfylte QC-kriteriene

9. september 2026

Først lagt ut (Faktiske)

15. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. september 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PRO00043004

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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

Tilgangskriterier for IPD-deling

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-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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