GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)

What Was Tested

This registered phase 4 trial tested Dulaglutide for pcos.

Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities.

Visceral fat dysfunction is an important factor in the onset of PCOS.

It had two arms (groups): GLP-1 RAs and calorie restrict diet group (experimental) and calorie restrict diet group (active comparator).

The registry classes the interventions as drug and other.

Who Took Part

68 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Female aged 18- 45;. Meet 2003 Rotterdam criteria;.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: treatment with any other drugs that may interfere with the trial, including traditional chinese medicine, contraceptives, metformin, glp-1ra or pioglitazone within the last 3 months；; chronic kidney disease or severe liver dysfunction；; malignant tumors；.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The pcos participants were allocated by chance, so the Dulaglutide group and the comparison group should start out alike.

The Dulaglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Dulaglutide study: the pcos participants and staff both knew the treatment.

It started in 2021-05-15 with completion listed for 2022-04-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the change in visceral adipose tissue (time frame: until achievement of the weight loss target,an average of 12 weeks).

It also tracked 32 secondary outcomes, for example menstrual frequency, systolic blood pressure, diastolic blood pressure, fasting plasma glucose, postprandial plasma glucose and fasting insulin.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Dulaglutide in 68 people with pcos.

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

More context: the Dulaglutide compound page, PCOS research.