A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese

NCT07326111 | Recruiting Phase 4

• 2 other identifiers: MED1-2022022024-515982-32-00
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 2

Brief Summary

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

Obesity & Overweight; Polycystic Ovary Syndrome (PCOS)

Keywords

pcos; tirzepatide; obesity; reproductive health; polycystic ovary syndrome

Outcome Measures

Primary Outcomes (2)

• Improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS

  1. Mean menstrual bleeding ratio (number of menstrual bleedings divided by treatment period in months) during the last 52 weeks of treatment, assessed at 72 weeks after randomization 2. Mean change in menstrual bleeding ratio from baseline, calculated at 72 weeks after randomization (with baseline defined as mean menstrual bleeding ratio during the 6 months before randomization)

  At 72 weeks after randomization

• Key Secondary - Improvement of ovarian dysfunction as defined by ovulation frequency in overweight or obesity-related PCOS

  Total number of biochemically confirmed ovulatory events (within 24 weeks after completed dose titration) measured by weekly serum progesterone

  Within 24 weeks after completed dose titration

Secondary Outcomes (21)

• Percentage of Participants With Normalization of Menstrual Cycle

  Week 72

• Change From Baseline in Serum Anti-Müllerian Hormone (AMH)

  Baseline and Week 72

• Change From Baseline in Biochemical Androgen Profile

  Baseline and Week 72

• Change From Baseline in Calculated Free Androgen Index (FAI) and Calculated Free Testosterone

  Baseline and Week 72

• Change From Baseline in Pituitary-Gonadal Hormones (LH, FSH, Estradiol, Progesterone)

  Baseline and Week 72

Other Outcomes (36)

• Dose-Dependent Menstrual Bleeding Ratio at Week 72

  Week 72

• Dose-Dependent Change in Mean Menstrual Bleeding Ratio at Week 72

  Baseline and Week 72

• Dose-Dependent Normalization of Menstrual Cycle

  72 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Weekly abdominal subcutaneous injection of tirzepatide over a 72-week treatment period including a 20-week dose-escalating regiment and 52-week treatment period adjunct to reduced-calorie diet and increased physical activity

Drug: Tirzepatide as an adjunct to lifestyle intervention

Control Group

PLACEBO COMPARATOR

Weekly abdominal subcutaneous injection of a placebo injectable over a 72-week period ad-junct to reduced-calorie diet and increased physical activity.

Drug: Placebo as an adjunct to lifestyle intervention

Interventions

Placebo as an adjunct to lifestyle intervention DRUG

Dose: Placebo Pens to mimic doses 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg Mode of Application: weekly subcutaneous injection, prefilled pen injector Duration of Treatment: 72 weeks

Control Group

Tirzepatide as an adjunct to lifestyle intervention DRUG

Doses: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg Mode of application: weekly subcutaneous injection, prefilled pen injector Duration of treatment: 72 weeks (20 weeks dose escalation, 52 weeks treatment with maximum tolerated dose)

Treatment Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: transgender men under gender-affirming hormone therapy (GAHT) are not eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent to participate in this clinical trial in accordance with local regulations and the ethical review board governing this clinical trial
• Subjects
• motivated, capable, and willing to self-inject IMP, as required for this protocol.
• motivated, capable, and willing to follow trial procedures for the duration of the clinical trial, includ-ing, but not limited to lifestyle, dietary and exercise advice.
• 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, defined by Rotterdam criteria
• 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
• 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

You may not qualify if:

• Subjects without legal capacity who are unable to understand the nature, scope, significance and consequences of this clinical trial
• 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
• Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investiga-tional product, up to 30 days after last IMP intake 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 malig-nancy for less than 5 years
• o Excluding basal- or squamous-cell skin cancer or in situ carcinomas of the cervix
• 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 deter-mined by the laboratory during screening
• History of gastric emptying abnormality (e.g., gastroparesis, gastric outlet obstruction or chronic de-pendence 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 treatment period from randomization, or nursing women
• Prior diagnosis of diabetes mellitus other forms than type 2
• o Note: Excluding prior history of gestational diabetes
• on DPP-4 inhibitors, GLP-1R agonist and/or a dual/triple incretin agonist (up to 6 months prior to screening)
• on sulfonylureas or insulin (basal and/or bolus)
• with uncontrolled diabetes (HbA1c \> 8.5%)

Sponsors & Collaborators

• University of Bonn: lead
• Heart and Diabetes Center North Rhine-Westphalia: collaborator
• University Hospital, Essen: collaborator
• Ruhr University of Bochum: collaborator
• LMU Klinikum: collaborator

Study Sites (2)

University Hospital BG Bergmannsheil Bochum General internal medicine, endocrinology and diabetology, gastroenterology and hepatology

Bochum, 44789, Germany

ENROLLING BY INVITATION

University Hospital Bonn Division of Endocrinology, Diabetes and Metabolism

Bonn, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity; Overweight

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Wiebke K. Fenske, Professor

  BG UniversitätsklinikumBergmannsheil Bochum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wiebke Fenske K. Head of Department at BG Universitätsklinikum Bochum, Professor

CONTACT

+49 234 302 3613; wiebke.fenske@bergmannsheil.de

Charlotte Fries M. Senior Physician, MD

CONTACT

+49 228 287 52533; charlotte.fries@ukbonn.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician

Model Details: Multi-centre, prospective, randomized, double-blind and placebo-controlled

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: January 8, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The data will be shared immediately following publication and ending 10 years following publication.
• Access Criteria: To gain access, data requestors will need to sign a data access agreement.

Locations

DE (2)