Actively Recruiting
A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese
Led by University of Bonn · Updated on 2026-01-08
198
Participants Needed
2
Research Sites
207 weeks
Total Duration
On this page
Sponsors
U
University of Bonn
Lead Sponsor
H
Heart and Diabetes Center North Rhine-Westphalia
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical study examines whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome (PCOS) who are overweight or have obesity. Tirzepatide is already approved for the treatment of diabetes and obesity, but its effects on ovarian dysfunction in PCOS are not yet known. Participants will be randomly assigned to tirzepatide or placebo in a double-blinded manner. The goal of the study is to demonstrate that tirzepatide, at the maximum tolerated dose, is superior to placebo for improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS. All participants will have a screening visit, followed by 72 weeks of treatment. Treatment includes a 20-week dose-escalation period and a 52-week maintenance period. Lower doses may be used if side effects occur, and the highest tolerated dose will be continued through the maintenance phase. A 4-week safety follow-up will take place after treatment, and long-term follow-up will continue for one year. The study will take place at five clinical trial sites in Germany.
CONDITIONS
Official Title
A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent to participate in the clinical trial
- Motivated, capable, and willing to self-inject investigational medication as required
- Motivated, capable, and willing to follow trial procedures including lifestyle, dietary, and exercise advice
- Motivated, capable, and willing to complete trial diaries and questionnaires
- Female aged 18 to 45 years of childbearing potential
- At least 3 years post-menarche and premenopausal
- Body mass index (BMI) of 27 kg/m2 or higher
- Previous diagnosis of PCOS defined by Rotterdam criteria
- Oligomenorrhea or secondary amenorrhea with irregular periods (cycle length less than 21 or more than 35 days or fewer than 8 cycles per year) within the last 10 years if on hormonal contraceptives, or within the last year if not
- Biochemical signs of hyperandrogenism with total testosterone in upper 95th percentile and free androgen index above upper limit of normal, and/or clinical signs of hyperandrogenism
- Hormonal contraceptive naive or not on hormonal contraceptives for six months prior to screening
- Willing to avoid hormonal contraceptives during the 72-week treatment and use safe alternate contraception during treatment and 30 days after last dose
You will not qualify if you...
- Unable to understand the nature and consequences of the clinical trial
- Physical or psychiatric conditions that may pose risk, interfere with participation, or confound results
- Lifetime suicidal event
- Participation in another clinical trial involving investigational product within 30 days prior
- Known or persistent abuse of medication, drugs, or alcohol
- History of active or untreated malignancy or remission less than 5 years (excluding certain skin and cervical cancers)
- Severe renal impairment (eGFR below 30 mL/min/1.73 m2)
- Acute or chronic hepatitis or other liver diseases except non-alcoholic fatty liver disease
- Alanine aminotransferase (ALT) level more than 3 times upper normal limit
- History of gastric emptying abnormalities
- Current or planned pregnancy or nursing
- Diabetes mellitus other than type 2
- Type 2 diabetes treated with certain medications or uncontrolled diabetes (HbA1c above 8.5%)
- Prior treatment with GLP-1 receptor agonists or dual incretin agonists within 6 months
- Use of inositol formulations within 6 months
- Congenital adrenal hyperplasia
- Untreated thyroid, pituitary, or adrenal disease
- Hyperprolactinaemia
- Known benign intrauterine lesions
- Hysterectomy
- Hypersensitivity to tirzepatide or related ingredients
- Personal or family history of medullary thyroid cancer or MEN 2 syndrome
- Elevated calcitonin levels beyond specified thresholds
- Secondary causes of obesity or genetic/syndromic obesity forms
- History of pancreatitis
- Previous or planned bariatric surgery or device-based obesity therapy
- Vaginal bleeding of unknown cause
- Known thromboembolic events or active thrombophlebitis
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University Hospital BG Bergmannsheil Bochum General internal medicine, endocrinology and diabetology, gastroenterology and hepatology
Bochum, Germany, 44789
Enrolling by Invitation
2
University Hospital Bonn Division of Endocrinology, Diabetes and Metabolism
Bonn, Germany, 53127
Actively Recruiting
Research Team
W
Wiebke Fenske K. Head of Department at BG Universitätsklinikum Bochum, Professor
CONTACT
C
Charlotte Fries M. Senior Physician, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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