Study on Tirzepatide for Women with Overweight or Obesity and Polycystic Ovary Syndrome (PCOS)

1 1 1

What is this study about?

This clinical trial investigates the use of tirzepatide (LY3298176) in women with Polycystic Ovary Syndrome (PCOS) who are also experiencing overweight or obesity. PCOS is a hormonal disorder common among women of reproductive age that can cause irregular menstrual periods, excess male hormone levels, and small cysts on the ovaries. Women with PCOS often experience ovarian dysfunction, which includes menstrual irregularity and problems with ovulation.

The purpose of this study is to determine if tirzepatide is more effective than placebo in improving ovarian function in women with PCOS who have overweight or obesity. Tirzepatide is a medication that helps regulate blood sugar and can promote weight loss. The study will focus specifically on whether the medication can help normalize menstrual cycles in women with PCOS.

Participants will receive either tirzepatide or placebo through self-injection for 72 weeks (approximately 1.5 years). Throughout the study, researchers will track menstrual cycles, measure hormone levels in the blood, monitor changes in body weight and composition, and assess various health indicators related to metabolism and quality of life. Participants will need to avoid hormonal contraceptives during the study period and use alternative barrier methods for contraception.

1 Starting the clinical trial

After joining the study, you will be randomly assigned to receive either tirzepatide (study medication) or a placebo (looks identical but contains no active medication).

This is a 72-week (approximately 1.5 years) trial for women aged 18-45 who have Polycystic Ovary Syndrome (PCOS) with irregular menstrual periods and are overweight or have obesity.

2 Medication administration

You will need to self-inject the study medication or placebo using an auto-injector device.

If assigned to tirzepatide, your dose will start low and gradually increase to the maximum tolerated dose. Possible doses include 2.5, 5, 7.5, 10, 12.5, and 15 mg.

You will continue these injections for the entire 72-week treatment period.

3 Contraception requirements

During the entire 72-week treatment period and for 30 days after your last dose, you cannot use hormonal contraceptives.

You will need to use barrier methods of contraception (such as condoms) during this time.

4 Regular monitoring

Throughout the study, you will have regular blood tests to monitor various hormone levels, including testosterone, estradiol, progesterone, and others.

You will need to track and record your menstrual periods for the entire study duration.

Weekly blood samples will be taken to measure progesterone levels to identify if ovulation is occurring.

5 Physical measurements

Your weight, waist circumference, and body composition will be measured regularly throughout the study.

Blood pressure readings will be taken at clinic visits.

Tests will be performed to assess your blood sugar levels, including fasting glucose and HbA1c (a measure of average blood sugar over the past 3 months).

6 Additional testing

You will undergo tests to check your liver function, including blood tests and possibly other measurements of liver stiffness and fat content.

Blood samples will be taken to measure cholesterol and triglyceride levels.

An oral glucose tolerance test (oGTT) may be performed, which involves drinking a glucose solution and having blood drawn at specific times afterward.

7 Questionnaires

You will complete several quality of life questionnaires during the study, including the SF-36, PGI-S, EQ-5D-5L, and PCOSQ (a PCOS-specific quality of life questionnaire).

These questionnaires will help assess how the treatment affects your overall wellbeing and PCOS symptoms.

8 Study completion

After completing the 72-week treatment period, final assessments will be conducted to evaluate the effectiveness of the treatment.

The main focus will be on whether your menstrual cycle has normalized (defined as cycle length between 21-35 days or more than 8 cycles per year).

Who Can Join the Study?

Female aged 18-45 years who can become pregnant
At least 3 years after first menstrual period and still having menstrual cycles
Body Mass Index (BMI) of 27 or higher (overweight or obesity)
Previous diagnosis of Polycystic Ovary Syndrome (PCOS)
Irregular periods (cycle less than 21 days or more than 35 days, or fewer than 8 cycles per year) within the last 10 years (if currently using hormonal birth control) OR in the last year (if not using hormonal birth control)
High male hormone levels in blood tests OR visible signs of high male hormones (such as excess facial/body hair or acne)
Either never used hormonal birth control OR not used it for at least 6 months before screening
Willing to use non-hormonal birth control methods (like condoms) during the 72-week study period and for 30 days after
Able and willing to give written informed consent
Willing and able to self-inject the study medication
Motivated to follow all study procedures, including lifestyle, diet and exercise advice
Willing to complete study diaries and questionnaires

Who Cannot Join the Study?

You cannot participate if you are pregnant, plan to become pregnant during the study, or are breastfeeding.
You cannot join if you have a body mass index (BMI) less than 27 kg/m² (BMI is a measure of body fat based on height and weight).
You are not eligible if you have type 1 or type 2 diabetes.
You cannot participate if you have had a recent heart attack, stroke, or other major heart problems.
You cannot join if you have severe kidney problems or liver disease.
You are excluded if you have a personal or family history of medullary thyroid cancer (a rare type of thyroid cancer) or Multiple Endocrine Neoplasia syndrome type 2 (an inherited condition that causes tumors in endocrine glands).
You cannot participate if you have pancreatitis (inflammation of the pancreas) or a history of this condition.
You are not eligible if you are taking weight loss medications or have had weight loss surgery.
You cannot join if you have a history of suicidal thoughts or behaviors.
You are excluded if you have used other investigational drugs within 30 days before starting this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum	Bad Oeynhausen	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Uptvmbyqxlahwarbnblkq Evkjk Awq	Essen	Germany
Bmnmpdpmuqaodvvqjukdrqtstj Uecnjzjsjgupmahvgofws Bqvlodcrszsxf gtrqh	Bochum	Germany
Kkyhnvwm dwk Ukuirlwibtgv Mrpxebqr Aff	Munich	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.10.2025

Trial locations

Investigated drugs:

Tirzepatide (LY3298176) is a medication that acts as both a GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist. It helps regulate blood sugar levels and may assist with weight management. In this study, it’s being tested to see if it can improve ovarian function and menstrual regularity in people with polycystic ovary syndrome (PCOS) who are overweight or obese.

Placebo is an inactive substance that looks like the real medication but contains no active ingredients. It’s used as a comparison to determine if the active medication (tirzepatide) is effective.

Investigated diseases:

Polycystic Ovary Syndrome (PCOS) – A common hormonal disorder among women of reproductive age characterized by enlarged ovaries with small cysts on the outer edges. PCOS involves irregular or prolonged menstrual periods, excess male hormone (androgen) levels, and polycystic ovaries. The condition can cause hirsutism (excessive hair growth), acne, and male-pattern baldness. Many women with PCOS have insulin resistance, meaning their cells can’t use insulin properly. The exact cause remains unknown, though genetics, insulin resistance, and inflammation have been linked to the disorder’s development.

Overweight or Obesity – A medical condition characterized by excessive accumulation of body fat that may impair health. It develops when energy intake from food and drink consumption is greater than energy expenditure through physical activity and bodily functions over a prolonged period. Body Mass Index (BMI) is commonly used to classify overweight (BMI of 25-29.9) and obesity (BMI of 30 or higher). Excess weight progressively affects multiple body systems and can lead to metabolic changes. Overweight and obesity are associated with alterations in hormonal balance, including increased insulin resistance.

Trial ID:

2024-515982-32-00

Protocol code:

MED1-202202

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Tirzepatide for Women with Overweight or Obesity and Polycystic Ovary Syndrome (PCOS)

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?