OncoMatch/Clinical Trials/NCT07326111
A Clincial Study Testing Tirzepatide on Reproductive Function and Metabolic Health in Women With PCOS Who Are Overweight or Obese
Is NCT07326111 recruiting? Yes, currently enrolling (May 2026). This Phase 4 trial studies Tirzepatide as an adjunct to lifestyle intervention for polycystic ovary syndrome (pcos).
Treatment: Tirzepatide as an adjunct to lifestyle intervention — 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.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Cannot have received: GLP-1R agonist
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
Cannot have received: dual incretin agonist
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
Cannot have received: DPP-4 inhibitor
on DPP-4 inhibitors (up to 6 months prior to screening)
Cannot have received: sulfonylurea
on sulfonylureas
Cannot have received: insulin
on insulin (basal and/or bolus)
Cannot have received: inositol formulation
Use of inositol formulations (up to 6 months prior to screening)
Lab requirements
Kidney function
eGFR ≥ 30 mL/min/1.73 m²; no severe renal impairment
Liver function
ALT ≤ 3.0 X ULN; no acute or chronic hepatitis; no other liver disease except non-alcoholic fatty liver disease
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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