Efficacy of Mazdutide for Treating PCOS

What Was Tested

This registered phase 1, phase 2 trial tested Mazdutide for 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.

It had 1 arm (groups): Mazdutide Treatment Arm (experimental).

Subcutaneous injection of Mazdutide once weekly for 24 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 43 actual participants took part.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 :. Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: 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; type 1 or type 2 diabetes mellitus.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Mazdutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-10-21 with completion listed for 2026-09-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Free Androgen Index (FAI) (time frame: 24 weeks).

It also tracked 7 secondary outcomes, for example Times of regular menses, Number of immature follicles, Bilateral ovary volume, Serum anti-Mullerian hormone (AMH), HOMA insulin resistance index (HOMA-IR) and HbA1c.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Mazdutide in 43 people with pcos.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Mazdutide compound page, PCOS research.