Clinical trial · Interventional
Efficacy of Mazdutide for Treating PCOS
A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome
NCT06519656CI-TRIAL-00081896completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mazdutide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mazdutide Treatment Arm
- description
- Subcutaneous injection of Mazdutide once weekly for 24 weeks.
- interventionNames
- Drug: Mazdutide
Primary outcomes (1)
- measure
- Free Androgen Index (FAI)
- timeFrame
- 24 weeks
- description
- FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100
Secondary outcomes (7)
- measure
- Times of regular menses
- timeFrame
- 24 weeks
- description
- Record of vaginal bleeding within 24 weeks after using Mazdutide
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * BMI≥28kg/M2 * No plan for pregnancy in the coming 8 months after enrollment * Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS : 1. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle 2. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound 3. Biochemical hyperandrogenism: total testosterone\>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)\>4 Exclusion Criteria: * Previous history of acute or chronic pancreatitis or pancreatic injury * Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b * Severe hypertriglyceridemia (TG\>5mmol/L) * Type 1 or type 2 diabetes mellitus * Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc * Pregnancy or breast-feeding * Patients with other serious diseases affecting heart, liver, kidney, or other major organs * Patients with any type of cancer
References
Publications (0)
Data not yet available
No reference posted for this study.