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A Clinical Trial of Tirzepatide (LY3298176) in Subjects With Overweight or Obesity and PCOS-related Ovarian Dysfunction (PERIODS)
EU CTIS ID: 2024-515982-32-00
What this study is testing
To demonstrate that tirzepatide in its maximum tolerated dose is superior to placebo for improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial
- Biochemical signs of hyperandrogenism with total testosterone in upper 95th Percentile AND free androgen index (FAI) > ULN and/or clinical signs of hyperandrogenism
- Hormonal contraceptive naïve or not on hormonal contraceptives six months prior to screening, willing to be without hormonal contraceptives for the duration of the clinical trial and to perform safe alternate contraception (barrier methods) during the 72-week IMP intake period and 30 days after the last dose of IMP
- Subject is motivated, capable, and willing to self-inject IMP, as required for this protocol
- Subject is motivated, capable, and willing to follow trial procedures for the duration of the clinical trial, including, but not limited to lifestyle, dietary and exercise advice
- Subject is motivated, capable, and willing to complete trial diaries and required questionnaires
You likely can't join if
- Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial
- Prior diagnosis of diabetes mellitus other forms than type 2
- In case of diabetes mellitus type 2: on DPP-4 inhibitors, GLP-1R agonist, a dual/triple incretin agonist (up to 6 months prior to screening)
- In case of diabetes mellitus type 2: on sulfonylureas or insulin (basal and/or bolus)
- In case of diabetes mellitus type 2: with uncontrolled diabetes (HbA1c > 8.5%)
- In case of diabetes mellitus type 2: with non-proliferative diabetic retinopathy requiring acute treatment
See the full eligibility criteria
Who can join
- Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial
- Biochemical signs of hyperandrogenism with total testosterone in upper 95th Percentile AND free androgen index (FAI) > ULN and/or clinical signs of hyperandrogenism
- Hormonal contraceptive naïve or not on hormonal contraceptives six months prior to screening, willing to be without hormonal contraceptives for the duration of the clinical trial and to perform safe alternate contraception (barrier methods) during the 72-week IMP intake period and 30 days after the last dose of IMP
- Subject is motivated, capable, and willing to self-inject IMP, as required for this protocol
- Subject is motivated, capable, and willing to follow trial procedures for the duration of the clinical trial, including, but not limited to lifestyle, dietary and exercise advice
- Subject is motivated, capable, and willing to complete trial diaries and required questionnaires
- Females aged 18 – 45 years of childbearing potential
- At least 3 years post-menarche and premenopausal
- BMI ≥ 27 kg/m²
- Previous diagnosis of PCOS
- Oligomenorrhea or secondary amenorrhea with irregular periods (defined as cycle length less than 21 or more than 35 days or < 8 cycles per year); within the last 10 years (if currently receiving hormonal contraceptive treatment) OR over the last year in the absence of hormonal contraceptive treatment
What rules you out
- Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial
- Prior diagnosis of diabetes mellitus other forms than type 2
- In case of diabetes mellitus type 2: on DPP-4 inhibitors, GLP-1R agonist, a dual/triple incretin agonist (up to 6 months prior to screening)
- In case of diabetes mellitus type 2: on sulfonylureas or insulin (basal and/or bolus)
- In case of diabetes mellitus type 2: with uncontrolled diabetes (HbA1c > 8.5%)
- In case of diabetes mellitus type 2: with non-proliferative diabetic retinopathy requiring acute treatment
- In case of diabetes mellitus type 2: with diabetic maculopathy
- Current or prior treatment (up to 6 months prior to screening) with GLP-1R agonist or a dual incretin agonist for obesity or other indications
- Use of inositol formulations (up to 6 months prior to screening)
- Congenital adrenal hyperplasia (CAH, classic and non-classic forms)
- Thyroid, pituitary, and/or adrenal disease (if not appropriately treated)
- Subjects with a physical or psychiatric condition which at the investigator’s discretion may put the subject at risk, may confound the trial results, or may interfere with the subject’s participation in this clinical trial
- Hyperprolactinaemia
- Known history of benign intrauterine lesions
- Hysterectomy
- Known history of hypersensitivity against tirzepatide or excipients
- Known personal or family history of medullary thyroid cancer or subjects with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Elevated calcitonin levels as determined by the laboratory during screening: ≥ 20 ng/L, if eGFR ≥ 60 mL/min/1.73 m2 ≥ 35 ng/L, if eGFR < 60 mL/min/1.73 m2
- Known secondary cause of obesity (i.e., Cushing syndrome) or monogenetic or syndromic forms of obesity (i.e., melanocortin 4 receptor deficiency or Prader Willi Syndrome)
- Known history of acute or chronic pancreatitis
- Previous or planned bariatric surgery or endoscopic and/or device-based therapy for obesity
- Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days after last IMP in-take in that clinical trial
- Known or persistent abuse of medication, drugs or alcohol
- History of an active or untreated malignancy or being in remission from a clinically significant malignancy for less than 5 years
- Prior diagnosis of severe renal impairment or measured as estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² during screening
- Acute or chronic hepatitis, signs and symptoms of any other liver disease other than non-alcoholic fatty liver disease, or alanine aminotransferase (ALT) level > 3.0 X the upper limit of normal, as determined by the laboratory during screening
- History of gastric emptying abnormality (e.g., gastroparesis, gastric outlet obstruction or chronic dependence on drugs that significantly affect gastric emptying)
- Current (positive pregnancy test, e.g., ß-HCG test in urine / serum) or planned pregnancy during the 72-week IMP intake period and 30 days after the last dose of IMP, or nursing women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.