Study S001540

A Clinical Trial of Tirzepatide (LY3298176) in Subjects With Overweight or Obesity and PCOS-related Ovarian Dysfunction

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT07326111
Acronym: PERIODS
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: QUADRUPLE
Status: RECRUITING
Enrollment: 198
Start: 2025-12-09
Primary completion: 2028-12
Lead sponsor: University of Bonn
Conditions: Polycystic Ovary Syndrome (PCOS); Obesity & Overweight
Interventions: DRUG:Tirzepatide as an adjunct to lifestyle intervention; DRUG:Placebo as an adjunct to lifestyle intervention
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: CTIS:2024-515982-32-00

Registered primary outcomes

Improvement of ovarian dysfunction as defined by menstrual irregularity in overweight or obesity-related PCOS [At 72 weeks after randomization]
Key Secondary - Improvement of ovarian dysfunction as defined by ovulation frequency in overweight or obesity-related PCOS [Within 24 weeks after completed dose titration]

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