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

9 septembre 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

48

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • Texas
      • Houston, Texas, États-Unis, 77030
      • Houston, Texas, États-Unis, 77030
      • Houston, Texas, États-Unis, 77030
      • Houston, Texas, États-Unis, 77030

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Dispositif: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pathological Response Rate
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time to response
Délai: 12 months
Time to response in months from treatment initiation to first documented histopathological regression
12 months
Adverse events
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Body weight change
Délai: 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
Délai: 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
Délai: 12 months
Change in waist circumference, measured in centimeters, from baseline to 6 and 12 months following treatment initiation.
12 months
Hip circumference change
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

The Methodist Hospital Research Institute

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 janvier 2027

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2031

Dates d'inscription aux études

Première soumission

9 septembre 2026

Première soumission répondant aux critères de contrôle qualité

9 septembre 2026

Première publication (Réel)

15 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PRO00043004

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime 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.

Délai de partage IPD

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

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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