EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)

What Was Tested

The trial (phase 3) is built around Exenatide for pcos.

This is a randomized, single-blind, parallel 5 treatment group 24-week trial designed to directly compare the therapeutic effects of exenatide once weekly (EQW), dapagliflozin (DAPA), EQW plus DAPA, combined DAPA/metformin extended release (XR) and the weight loss medication, phentermine/topiramate extended release (PHEN/TPM ER) on metabolic and endocrinological parameters in overweight/obese non-diabetic women with PCOS.

The researchers hope to determine which treatment(s) addressing the multifaceted disturbances of individual subgroups emerge as the preferable therapy.

It had five arms (groups): Exenatide once weekly (EQW ) (experimental), Dapagliflozin (DAPA) (experimental), EQW plus DAPA (experimental), Dapagliflozin plus Glucophage (MET ER) (experimental) and Phentermine /Topiramate (PHEN/ TPM) ER (active comparator).

The registry classes the interventions as drug.

More on the Plan

Polycystic ovary syndrome is a heterogeneous condition characterized by disordered reproductive and metabolic function which accounts for the myriad of clinical features including androgen excess, chronic anovulation, insulin resistance adiposity, and dyslipidemia.

Hyperandrogenism, ovarian dysfunction and metabolic abnormalities - the main determinants of PCOS - all appear to be involved in a synergistic way in the pathophysiology of PCOS.

Obesity, particularly abdominal obesity, plays a central role in the development of PCOS, and exacerbates the reproductive and metabolic dysfunction.

Rather than absolute body weight, it is the distribution of fat that is important with central (visceral) adiposity being a risk factor.

Who Took Part

Enrollment: 119 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Non-diabetic women (18-45 years). PCOS- NIH criteria hyperandrogenism and irregular menses. Obese class I, II, and III (BMI \>30\<45). An intrauterine device, tubal sterilization, or male partner vasectomy, or. Combination of two barrier methods with one being male condom.

The full record lists 7 inclusion and 23 exclusion criteria; among the exclusions: uncontrolled thyroid disease (documented normal tsh), cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia; untreated or poorly controlled hypertension (sitting blood pressure \> 160/95 mm hg); prior history of a malignant disease requiring chemotherapy.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

Only one side, usually the pcos participants, was kept unaware of whether Exenatide was given.

Those kept unaware of assignments: investigator.

It started in 2016-03-22 with completion listed for 2020-07-22.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Oral Disposition (Insulin Sensitivity-insulin Secretion) Index (time frame: 24 weeks of treatment).

It also tracked 22 secondary outcomes, for example Absolute Body Weight, Body Mass Index (BMI), Change in Percent Body Weight, Central Adiposity (Waist Circumference), Waist-to-Hip Ratio (WHR) and Waist-to-Height Ratio (WHtR).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 119 people with pcos.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, PCOS research.