Actively Recruiting
A Clinical Trial of Tirzepatide (LY3298176) in Subjects With Overweight or Obesity and PCOS-related Ovarian Dysfunction
Led by University of Bonn · Updated on 2026-01-08
198
Participants Needed
2
Research Sites
52 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
Researchers are investigating whether tirzepatide can improve ovarian dysfunction in premenopausal women with polycystic ovary syndrome (PCOS) who are overweight or have obesity. This phase IV, multi-center, randomized, double-blind, placebo-controlled trial aims to show that tirzepatide at the maximum tolerated dose is better than placebo for improving menstrual irregularity related to PCOS. The study is conducted at five sites in Germany and focuses on women aged 18 to 45 years with PCOS defined by specific criteria.
CONDITIONS
Brief 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 this clinical trial
- Females aged 18 to 45 years of childbearing potential
- At least 3 years post-menarche and premenopausal
- Body mass index (BMI) of 27 kg/m8 or higher
- Previous diagnosis of PCOS defined by Rotterdam criteria
- Oligomenorrhea or secondary amenorrhea with irregular periods 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 normal, or clinical signs of hyperandrogenism
- Hormonal contraceptive naive or off hormonal contraceptives for six months prior to screening and willing to use barrier contraception during treatment
- Motivated and able to self-inject investigational medicinal product and follow trial procedures including lifestyle changes
- Willing and able to complete trial diaries and questionnaires
You will not qualify if you...
- Unable to understand the nature and consequences of this clinical trial
- Physical or psychiatric conditions that may pose risk or interfere with participation
- Lifetime history of suicidal events
- Participation in another clinical trial within 30 days prior to screening
- Known or persistent abuse of medication, drugs, or alcohol
- History of active or untreated malignancy within the last 5 years (excluding certain skin cancers and cervical carcinoma in situ)
- Severe renal impairment (eGFR < 30 mL/min/1.73 m8)
- Acute or chronic hepatitis or other liver diseases excluding non-alcoholic fatty liver disease
- History of gastric emptying abnormalities
- Current or planned pregnancy or nursing
- Diabetes mellitus other than type 2, or type 2 diabetes with certain treatments or complications
- Prior treatment with GLP-1 receptor agonists or dual incretin agonists within 6 months
- Use of inositol formulations within 6 months
- Congenital adrenal hyperplasia or untreated thyroid, pituitary, or adrenal disease
- Hyperprolactinemia
- History of benign intrauterine lesions or hysterectomy
- Allergies to tirzepatide or related medications
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2
- Elevated calcitonin levels above specified thresholds
- Secondary causes of obesity or syndromic forms
- History of pancreatitis
- Previous or planned bariatric or device-based obesity treatments
- Vaginal bleeding of unknown cause
- History of thromboembolic events or active thrombophlebitis
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 72 weeks (20 weeks dose escalation, 52 weeks maintenance)
Participants receive weekly abdominal subcutaneous injections of tirzepatide or placebo, along with a reduced-calorie diet and increased physical activity. The treatment includes a 20-week dose escalation period followed by a 52-week maintenance period with the maximum tolerated dose.
Weekly visits for injections and assessments during the 72-week treatment period
Duration - 4 weeks
Participants are monitored for safety for 4 weeks after completing or discontinuing the investigational medicinal product during the treatment period.
1 to 2 visits depending on participant status
Duration - 1 year
Participants are followed for one year after discontinuation of the investigational medicinal product to monitor long-term effects.
Periodic visits over one year
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
C
Charlotte Fries M. Senior Physician, MD
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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