Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients

What Was Tested

This registered phase 4 trial tested Exenatide for pcos.

Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks.

Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.

It had two arms (groups): Metformin (active comparator) and Metformin+EQW (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 80 planned participants were the target.

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: Females 18 years to 40 years of age. Diagnosed as PCOS by the 2003 Rotterdam criteria. Overweight/obesity (BMI≥25 kg/m2). No pregnant plan in recent 6 months. Written consent for participation in the study.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: type 1 or type 2 diabetes mellitus; subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, cushing's syndrome, thyroid diseases, and hyperprolactinemia; diagnosed with or have a family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2).

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Exenatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the pcos participants stayed in one arm throughout.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-07-20 with completion listed for 2020-02-28.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in body weight (time frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial).

It also tracked 27 secondary outcomes, for example Change in body mass index (BMI), Change in waist circumference(WC), Change in hip circumference (HC), Changes in lipid accumulation product(LAP), Changes in Visceral obesity index(VAI) and Changes in blood pressure.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 80 people with pcos.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, PCOS research.