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

Sponsor
University of Bonn
Study ID
NCT07326111
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Obesity & Overweight
  • Polycystic Ovary Syndrome (PCOS)

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • 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)
  • 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

Study Details

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.

Key Dates

Start date
Dec 9, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
198 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment Group
    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
  • Placebo Comparator: Control Group
    Weekly abdominal subcutaneous injection of a placebo injectable over a 72-week period ad-junct to reduced-calorie diet and increased physical activity.

Primary Outcome Measure

Improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS [ Time Frame: At 72 weeks after randomization ]

Central Contacts

  • Wiebke Fenske K. Head of Department at BG Universitätsklinikum Bochum, Professor
    +49 234 302 3613
    [email protected]
  • Charlotte Fries M. Senior Physician, MD
    +49 228 287 52533
    [email protected]

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