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

9 settembre 2026 aggiornato da: 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

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

48

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Texas
      • Houston, Texas, Stati Uniti, 77030
      • Houston, Texas, Stati Uniti, 77030
      • Houston, Texas, Stati Uniti, 77030
      • Houston, Texas, Stati Uniti, 77030

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: 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.
Dispositivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pathological Response Rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to response
Lasso di tempo: 12 months
Time to response in months from treatment initiation to first documented histopathological regression
12 months
Adverse events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Body weight change
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 12 months
Change in waist circumference, measured in centimeters, from baseline to 6 and 12 months following treatment initiation.
12 months
Hip circumference change
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Methodist Hospital Research Institute

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 gennaio 2027

Completamento primario (Stimato)

31 dicembre 2028

Completamento dello studio (Stimato)

31 dicembre 2031

Date di iscrizione allo studio

Primo inviato

9 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 settembre 2026

Primo Inserito (Effettivo)

15 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 settembre 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PRO00043004

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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