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

NCT02635386 · Completed

Last updated 2026-05-28

This clinical trial is testing different medication combinations (including extended-release versions) in obese women who have polycystic ovary syndrome to study their effects on insulin sensitivity and secretion.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 119 people

Who can join Ages 18–45 · female only Healthy volunteers accepted.

Timeline Started 2016-03 · est. completion 2020-10

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT02635386 ↗

Description as written by the study sponsor.

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. In this study, we will examine the efficacy of these therapies on metabolic parameters, body weight and body composition, anthropometric measurements, and reproductive function in a well-defined group of pre-menopausal overweight/obese, non-diabetic women with PCOS, focusing on their relationship to insulin resistance and obesity. We hope to determine which treatment(s) addressing the multifaceted disturbances of individual subgroups emerge as the preferable therapy.

Treatments tested

Exenatide once weekly (EQW ) also known as • Bydureon, • Long acting glucagon like peptide 1 (GLP1) agonist Drug

2 mg SC injection every 7 days
Dapagliflozin (DAPA) also known as • Farxiga, • SGLT2 inhibitor Drug

One pill (10 mg) by mouth daily (QD) in am
EQW plus DAPA also known as Bydureon plus Farxiga, Long acting GLP1 agonist plus SGLT2 inhibitor Drug

2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
Dapagliflozin plus Glucophage (MET ER) also known as Xigduo, •Combination SGLT2 inhibitor and metformin ER Drug

DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
Phentermine /Topiramate (PHEN/ TPM) ER also known as Qsymia Drug

PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am

Main thing measured	Oral Disposition (Insulin Sensitivity-insulin Secretion) Index
Sponsor	Woman's
Conditions studied	Polycystic Ovary Syndrome, Obesity
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02635386 ↗