Drug + IUD & Weight Intervention for Hyperplasia

Overseen by Andrea R Hagemann, M.D., MSCI

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests if using semaglutide and an LNG-IUD together can help premenopausal women with thickened uterine linings keep their uterus, lose weight, and improve their quality of life. The levonorgestrel intrauterine device (LNG-IUD) has been used effectively for various conditions including thickened uterine linings, heavy menstrual bleeding, and as part of hormone replacement therapy.

Research Team

Andrea R Hagemann, M.D., MSCI

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with a specific type of abnormal uterine cell growth.

BMI ≥ 30 kg/m2

I have AEH and am on progestin therapy without having used GLP-1R agonists in the last 3 months.

Exclusion Criteria

History of suicidal attempts or active suicidal ideation

I have severe chronic heart failure.

I do not have any serious ongoing illnesses like heart problems or infections.

Treatment Details

Interventions

• Progestin (Hormone Therapy)
• Semaglutide (GLP-1R Agonist)
• Telemedicine Behavioral Weight Intervention (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Arm 1: Semaglutide + progestin Experimental Treatment 3 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 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.

Group II: Arm 2: Placebo + Progestin Active Control 3 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 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.

Semaglutide is already approved in Canada, Japan for the following indications:

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

Novo Nordisk A/S

Industry Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen