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.
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.
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
Note: Patients with depression or other psychiatric disorder whose disease state is considered stable and expected to remain stable throughout the course of the clinical trial, in the opinion of the investigator, may be considered for inclusion.
Note: Subjects with a lifetime suicidal event cannot be considered for inclusion
University of Bonn
Lead sponsor
University Hospital, Bonn
Sponsor institution
Heart and Diabetes Center North Rhine-Westphalia
Collaborator
University Hospital, Essen
Collaborator
Ruhr University of Bochum
Collaborator
LMU Klinikum
Collaborator