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Endometrial HyperplasiaPhase 2NCT05829460

Primary Prevention and Uterine Preservation in Premenopausal Women With Obesity and Endometrial Hyperplasia

A Phase 2 study testing Semaglutide, LNG-IUD (Progestin) and Telemedicine behavioral weight program in people with Endometrial Hyperplasia, run by Washington University School of Medicine.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The investigators hypothesize that combined treatment with the GLP-1R agonist semaglutide 2.4 mg and levonorgestrel intrauterine device (LNG-IUD), compared to LNG-IUD alone, will result in improved likelihood of uterine preservation, sustained weight loss, improved endometrial and metabolomic response to progestin… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Endometrial Hyperplasia
What is being tested?
Semaglutide, LNG-IUD (Progestin) and Telemedicine behavioral weight program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
12 Mar 2025to 30 Apr 2032
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosis of histologically confirmed non-atypical endometrial hyperplasia (EH) or complex atypical endometrial hyperplasia (AEH).
  • Patients with a previous diagnosis of EH or AEH who are already being followed with conservative management with oral or LNG-IUD progestin therapy are eligible provided they have not previously been on a GLP-1R agonist within 3 months prior to enrollment.
  • For patients with a previous diagnosis of EH or AEH who have been placed on progestin prior to study entry, the duration of IUD or oral progestin use prior to trial entry should be less than or equal to 6 months.
  • Premenopausal woman with a uterus.
  • At least 18 years of age and no more than 45 years of age.
  • Interested in uterine preservation/fertility-sparing treatment.
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  • BMI ≥ 30 kg/m2.
  • Prior or current receipt of progestin is allowed as above. Willingness to undergo placement of LNG-IUD at the time of study entry.
  • Prior or current receipt of metformin is allowed.
  • Ability to understand and willingness to sign an IRB approved written informed consent document.

Who cannot join

  • Prior use of GLP-1 receptor agonist (exenatide, liraglutide, or other) or pramlintide or any DPP-4 inhibitor in the 3 months prior to date of registration.
  • History of type 1 diabetes.
  • History of type 2 diabetes requiring use of insulin.
  • Acute decompensation of glycemic control.
  • Concomitant use of other weight management drugs or drugs for short-term weight loss.
  • History of surgery or use of a device to treat obesity.
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  • Uncontrolled thyroid disease
  • Acute coronary or cerebrovascular event in the previous 60 days.
  • Currently planned coronary, carotid, or peripheral artery revascularization.
  • Chronic heart failure (NYHA class IV).
  • Evidence of renal dysfunction as defined by creatinine clearance < 60 ml/minute.
  • History of solid organ transplant or awaiting solid organ transplant.
  • Diagnosis of any malignant neoplasm or current, active treatment with chemotherapy or radiation.
  • Family or personal history of multiple endocrine neoplasia syndrome type 2 (MEN 2) or familial medullary thyroid carcinoma (MTC).
  • A history of allergic reactions attributed to compounds of similar chemical or biologic composition to progestin, semaglutide, or other agents used in the study.
  • History of diabetic retinopathy.
  • Recent history of pancreatitis, defined as less than 6 months prior to enrollment.
  • History of suicidal attempts or active suicidal ideation.
  • Significant active psychiatric disease, including recent psychiatric inpatient admission or use of any psychiatric medications that are not stabilized.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Pregnant and/or breastfeeding. Participants must have a negative serum pregnancy test within 7 days of date of registration.
  • Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL, they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration, or they are receiving anti-retrovirals that affect progestin levels. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended.

About this study

The investigators hypothesize that combined treatment with the GLP-1R agonist semaglutide 2.4 mg and levonorgestrel intrauterine device (LNG-IUD), compared to LNG-IUD alone, will result in improved likelihood of uterine preservation, sustained weight loss, improved endometrial and metabolomic response to progestin, and improved quality of life in premenopausal women with endometrial hyperplasia who desire uterine preservation.

Being tested
Semaglutide, Placebo, LNG-IUD (Progestin), Telemedicine behavioral weight program
Medical subject headings
Endometrial Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SemaglutideDrug

    This medication is self-administered as a subcutaneous injection in the abdomen, thigh, or upper arm; injection site should be rotated when using the same body region.

  • PlaceboDrug

    This medication is self-administered as a subcutaneous injection in the abdomen, thigh, or upper arm; injection site should be rotated when using the same body region.

  • LNG-IUD (Progestin)Drug

    Released via the levonorgestrel-releasing IUD.

  • Telemedicine behavioral weight programBehavioural

    Optional to attend.

Study groups in NCT05829460
Study groupRoleWhat they receive
Arm 1: Semaglutide + progestinExperimental* 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 0.25 mg up to 2.4 mg). * Will be enrolled in a behavioral weight program that is optional to attend. The program will be delivered in a closed-group format. The group program will consist of 12 consecutive 60 minute weekly visits, and will recur every three months such that participants can join the soonest available Week 1 session after study enrollment. Each group session will focus on providing education and cognitive/behavioral strategies to achieve a healthier, reduced-calorie diet and a more physically active lifestyle. Cognitive/behavioral strategies will consist of goal setting, problem solving, cognitive restructuring, stimulus control, and stress management.
Receives: Drug: Semaglutide; Drug: LNG-IUD (Progestin); Behavioral: Telemedicine behavioral weight program
Arm 2: Placebo + ProgestinActive comparator* 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 be enrolled in a behavioral weight program that is optional to attend. The program will be delivered in a closed-group format. The group program will consist of 12 consecutive 60 minute weekly visits, and will recur every three months such that participants can join the soonest available Week 1 session after study enrollment. Each group session will focus on providing education and cognitive/behavioral strategies to achieve a healthier, reduced-calorie diet and a more physically active lifestyle. Cognitive/behavioral strategies will consist of goal setting, problem solving, cognitive restructuring, stimulus control, and stress management.
Receives: Drug: Placebo; Drug: LNG-IUD (Progestin); Behavioral: Telemedicine behavioral weight program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with endometrial hyperplasia free biopsy with uterine preservation

    Measured: At 2 years (or exit from study)

Secondary outcomes (5)

  1. Time to resolution of endometrial hyperplasia (EH)

    Measured: Through completion of follow-up (estimated to be 4 years)

  2. Change in weight

    Measured: From baseline to 2 years

  3. Change in Cancer Worry Impact of Events Scale (CWIES)

    The CWIES is a 15-item self-report measure evaluating stress reactions and traumatic experiences, specifically inquiring about cancer worry-specific distress. Range of values for each individual item will be a Likert Scale from 0-5. 0=not at all and 5=often. The higher the score, the more cancer-worry specific distress the participant has.

    Measured: At enrollment, 12 months, and end of treatment (estimated to be 2 years)

  4. Change in Impact of Weight on Quality of Life (IWQOL-Lite)

    The IWQOL-Lite provides a total score and scores for five subscales: physical function, self-esteem, sexual life, public distress and work. Scores range from 0 to 100 with lower scores indicating greater impairment.

    Measured: At enrollment, 12 months, and end of treatment (estimated to be 2 years)

  5. Hyperplasia-free survival

    Measured: Through completion of follow-up (estimated to be 4 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start12 Mar 2025
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion30 Apr 2032 (estimated)

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized on a 1:1 basis to either progestin + semaglutide 2.4 mg or progestin + placebo. Randomization will be stratified by previous progestin and metformin use.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05829460
Sponsor's protocol ID
202402083
Status last verified
Jan 2026
First submitted
12 Apr 2023
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Semaglutide, LNG-IUD (Progestin) and Telemedicine behavioral weight program in people with Endometrial Hyperplasia, run by Washington University School of Medicine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with endometrial hyperplasia free biopsy with uterine preservation (time frame: At 2 years (or exit from study)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05829460.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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