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GLP-1R Agonist

Drug + IUD & Weight Intervention for Hyperplasia

Phase 2
Waitlist Available
Led By Andrea R Hagemann, M.D., MSCI
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of histologically confirmed complex atypical endometrial hyperplasia
At least 18 years of age and no more than 45 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of follow-up (estimated to be 4 years)
Awards & highlights

Study Summary

This trial will test if combining a drug and an IUD can help women with endometrial hyperplasia keep their uterus and lose weight, while improving quality of life.

Who is the study for?
This trial is for premenopausal women aged 18-45 with obesity (BMI ≥ 30 kg/m2) and complex atypical endometrial hyperplasia who want to preserve their uterus. They must not have used GLP-1R agonists recently, have a history of certain diseases like MEN 2 or MTC, uncontrolled illnesses, renal dysfunction, or be pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests if semaglutide combined with a levonorgestrel intrauterine device (LNG-IUD) is more effective than LNG-IUD alone in preserving the uterus and aiding weight loss in women with endometrial hyperplasia. It also examines the impact on quality of life.See study design
What are the potential side effects?
Semaglutide may cause digestive issues, risk of pancreatitis, changes in blood sugar levels, and possible thyroid tumors. The LNG-IUD could lead to menstrual changes or discomfort where it's placed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a specific type of abnormal uterine cell growth.
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I am between 18 and 45 years old.
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I am willing to have an LNG-IUD placed for the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of follow-up (estimated to be 4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients with atypia-free biopsy with uterine preservation
Secondary outcome measures
Atypia-free survival
Change in Cancer Worry Impact of Events Scale (CWIES)
Change in Impact of Weight on Quality of Life (IWQOL-Lite)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: Semaglutide + progestinExperimental Treatment3 Interventions
The progestin will be delivered via the levonorgestrel-releasing IUD and it is standard of care. Will receive injectable pens containing semaglutide and will be self-administered on a weekly basis for up to 104 weeks. Dosing will be escalated during weeks 1 through 16 (start at 0.24 mg up to 2.4 mg). Will receive a telemedicine behavioral intervention delivered by a psychologist. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week
Group II: Arm 2: Placebo + ProgestinActive Control3 Interventions
The progestin will be delivered via the levonorgestrel-releasing IUD and it is standard of care. Will receive injectable pens containing the placebo and will be self-administered on a weekly basis for up to 104 weeks. Will receive a telemedicine behavioral intervention delivered by a psychologist. At each session, patients will self-report weight, number of days they kept a food journal during the past week, average daily caloric intake for the week, number of days exercised for the week, total number of minutes of moderate physical activity, and average number of steps per day for the week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160
Progestin
2015
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,928 Previous Clinical Trials
2,296,992 Total Patients Enrolled
1 Trials studying Endometrial Hyperplasia
96 Patients Enrolled for Endometrial Hyperplasia
Novo Nordisk A/SIndustry Sponsor
1,503 Previous Clinical Trials
2,385,718 Total Patients Enrolled
Andrea R Hagemann, M.D., MSCIPrincipal InvestigatorWashington University School of Medicine
1 Previous Clinical Trials
96 Total Patients Enrolled
1 Trials studying Endometrial Hyperplasia
96 Patients Enrolled for Endometrial Hyperplasia

Media Library

Semaglutide (GLP-1R Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05829460 — Phase 2
Endometrial Hyperplasia Research Study Groups: Arm 1: Semaglutide + progestin, Arm 2: Placebo + Progestin
Endometrial Hyperplasia Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05829460 — Phase 2
Semaglutide (GLP-1R Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05829460 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I meet the requirements to participate in this experiment?

"The criteria for this study requires that enrollees have endometrial hyperplasia and be between 18-45 years old. Currently, 96 participants are needed to complete the trial."

Answered by AI

Are there any age restrictions for enrollees in this trial?

"This study is intended for patients in the 18-45 year old age bracket. However, there are 23 trials available that cater to minors and 106 studies which focus on elderly participants."

Answered by AI

Has the Arm 1: Semaglutide + progestin combination been officially validated by the FDA?

"Arm 1: Semaglutide + progestin received a score of 2 on the safety scale due to limited evidence supporting its efficacy, but some information confirming its safe usage."

Answered by AI

Are there opportunities for enrollment in this research endeavor?

"As per clinicaltrials.gov, this particular clinical trial is not presently enrolling participants; the initial posting date was October 31st 2023 and it has been revised on April 24th of that same year. However, there are 131 other similar trials actively recruiting patients at present moment."

Answered by AI
~64 spots leftby Mar 2029