← Trials/Trial dossier/NCT02635386
EQW, DAPA, EQW/DAPA, DAPA/MET ER and PHEN/TPM ER in Obese Women With PolycysticOvary Syndrome (PCOS)
Comparison of Dapagliflozin (DAPA) and Once-weekly Exenatide (EQW), Co-administered or Alone, DAPA/ Glucophage (DAPA/MET ER) and Phentermine/Topiramate (PHEN/TPM) ER on Metabolic Profiles and Body Composition in Obese PCOS Women
Lead sponsor
Asset
Exenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
119
actual
Study population
Obesity / overweight, PCOS
Key I/E criteria
•BMI ≥30•Female
Primary endpoint
•Oral Disposition Index
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Non-diabetic women (18-45 years)
2. PCOS- NIH criteria hyperandrogenism and irregular menses
3. Obese class I, II, and III (BMI >30<45)
4. Willing to use effective contraception consistently during therapy which is defined as:
1. an intrauterine device, tubal sterilization, or male partner vasectomy, or
2. combination of two barrier methods with one being male condom.
5. Written consent for participation in the study
Exclusion criteria
1. Presence of significant systemic disease, heart problems including congestive heart failure, unstable angina or acute myocardial infarction, current infectious liver disease, acute stroke or transient ischemic attacks, history of pancreatitis, or diabetes mellitus (Type 1 or 2)
2. Any hepatic diseases in the past (infectious liver disease, viral hepatitis, toxic hepatic damage, jaundice of unknown etiology) or severe hepatic insufficiency and/or significant abnormal liver function tests defined as aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) >3x ULN
3. Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2) or history of unstable or rapidly progressing renal disease or end stage renal disease. Patients with a history of nephrolithiasis are also excluded due to increased association with kidney stone formation.
4. Uncontrolled thyroid disease (documented normal TSH), Cushing's syndrome, congenital adrenal hyperplasia or hyperprolactinemia
5. Significantly elevated triglyceride levels (fasting triglyceride > 400 mg/dL)
6. Untreated or poorly controlled hypertension (sitting blood pressure > 160/95 mm Hg)
7. Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, gonadotropin-releasing hormone agonists, glucocorticoids, anabolic steroids, C-19 progestins) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors (finasteride, spironolactone, flutamide) stopped for at least 4 weeks
8. Prior history of a malignant disease requiring chemotherapy
9. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status
10. History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit.
11. Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions
12. Known hypersensitivity or contraindications to use GLP1 receptor agonists (exenatide, liraglutide)
13. Use of metformin, thiazolidinediones, GLP-1 receptor agonists, dipeptidyl peptidase 4 (DPP-4) inhibitors, SGLT2 inhibitors stopped for at least 4 weeks.
14. Prior use of medication to treat diabetes except gestational diabetes
15. Eating disorders (anorexia, bulimia) or gastrointestinal disorders
16. Suspected pregnancy (documented negative serum pregnancy test), desiring pregnancy in next 6 months, breastfeeding, or known pregnancy in last 2 months
17. Active or prior history of substance abuse (smoke or tobacco use within past 3 years) or significant intake of alcohol
18. Having a history of bariatric surgery
19. Patient not willing to use two barrier method contraception during study period (unless sterilized or have an IUD)
20. Patients with glaucoma or history of increased intraocular pressure, or use of any medications to treat increased intraocular pressure
21. Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables. Patients with a history of bipolar disorder or psychosis, greater than one lifetime, episode of major depression, current depression of moderate or greater severity (PHQ-9score of 10 or more), presence or history of suicidal behavior or ideation with some intent to act on it, or antidepressant use that has not been stable for at least 3 months will also be excluded.
22. Inability or refusal to comply with protocol
23. Current participation or participation in an experimental drug study in previous three months
Endpoints (23)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
10 endpointsAbsolute Body Weight
Time frame:24 weeks of treatment
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), kilogram | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 100.4 | — |
| Dapagliflozin (DAPA) | 102.6 | — |
| EQW Plus DAPA | 99 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 101.2 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 97 | — |
Body Mass Index (BMI)
Time frame:24 weeks of treatment
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), kilogram/meter squared | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 37.3 | — |
| Dapagliflozin (DAPA) | 37.4 | — |
| EQW Plus DAPA | 36.7 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 37 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 35.3 | — |
Change in Percent Body Weight
Time frame:Change from baseline (time 0) to study end (24 weeks)
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), percentage change in body weight | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 3.8 | — |
| Dapagliflozin (DAPA) | 1.5 | — |
| EQW Plus DAPA | 6.9 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 1.7 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 8.1 | — |
One way ANOVA with Bonferroni test to compare differences between groups if significant
Central Adiposity (Waist Circumference)
Time frame:24 weeks of treatment
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), centimeters | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 104 | — |
| Dapagliflozin (DAPA) | 101 | — |
| EQW Plus DAPA | 106 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 101.3 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 97 | — |
Waist-to-Hip Ratio (WHR)
Time frame:24 weeks of treatment
ratio, improvement
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | .83 | — |
| Dapagliflozin (DAPA) | .79 | — |
| EQW Plus DAPA | .86 | — |
| Dapagliflozin Plus Glucophage (MET ER) | .83 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | .81 | — |
Waist-to-Height Ratio (WHtR)
Time frame:24 weeks of treatment
ratio, improvement
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | .64 | — |
| Dapagliflozin (DAPA) | .61 | — |
| EQW Plus DAPA | .65 | — |
| Dapagliflozin Plus Glucophage (MET ER) | .61 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | .59 | — |
Total Fat Mass (kg) Evaluated by DEXA
Time frame:24 weeks of treatment
Total fat mass
change from baseline, improvement
Posted result
| Group | Value (mean), kilogram | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 47.6 | — |
| Dapagliflozin (DAPA) | 47.8 | — |
| EQW Plus DAPA | 45.9 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 48 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 44.5 | — |
Total Body Fat (%) by DEXA
Time frame:24 weeks of treatment
Total fat mass
change from baseline, improvement
Posted result
| Group | Value (mean), percent fat mass | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 46.1 | — |
| Dapagliflozin (DAPA) | 46.4 | — |
| EQW Plus DAPA | 45.8 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 46.1 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 45.2 | — |
Android-Gynoid Ratio (AGR) as Determined by DEXA
Time frame:24 weeks of treatment
change from baseline, improvement
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 1.07 | — |
| Dapagliflozin (DAPA) | 1.02 | — |
| EQW Plus DAPA | 1.04 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 1.04 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 1.03 | — |
Trunk/Leg Fat Ratio by DEXA
Time frame:24 weeks of treatment
ratio, improvement
Posted result
| Group | Value (mean), ratio | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 1.03 | — |
| Dapagliflozin (DAPA) | .95 | — |
| EQW Plus DAPA | .93 | — |
| Dapagliflozin Plus Glucophage (MET ER) | .98 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | .99 | — |
Glycemic / diabetes
6 endpointsOral Disposition (Insulin Sensitivity-insulin Secretion) Index
Time frame:24 weeks of treatment
change from baseline, improvement
Posted result
| Group | Value (mean), index score | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 471 | — |
| Dapagliflozin (DAPA) | 311 | — |
| EQW Plus DAPA | 503 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 395 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 545 | — |
Fasting Blood Glucose
Time frame:24 weeks of treatment
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 91 | — |
| Dapagliflozin (DAPA) | 93 | — |
| EQW Plus DAPA | 86.5 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 89 | — |
| Phentermine /Topiramate (PHEN/ TPM ER | 91.4 | — |
OGTT Mean Blood Glucose (MBG)
Time frame:24 weeks of treatment
change from baseline, improvement
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 118 | — |
| Dapagliflozin (DAPA) | 126.4 | — |
| EQW Plus DAPA | 112 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 119 | — |
| Phentermine /Topiramate (PHEN/ TPM ER | 113 | — |
Fasting Insulin Sensitivity (HOMA-IR)
Time frame:24 weeks of treatment
HOMA-IR (insulin sensitivity)
ratio, improvement
Posted result
| Group | Value (mean), index score | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 3.7 | — |
| Dapagliflozin (DAPA) | 3.6 | — |
| EQW Plus DAPA | 2.6 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 3.3 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 3.4 | — |
Matsuda Sensitivity Index Derived From the OGTT(SI OGTT)
Time frame:24 weeks of treatment
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Value (mean), index score | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 3.1 | — |
| Dapagliflozin (DAPA) | 3.6 | — |
| EQW Plus DAPA | 3.9 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 4.8 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 4.7 | — |
Corrected First Phase Insulin Secretion (IGI/HOMA-IR)
Time frame:24 weeks of treatment
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Posted result
| Group | Value (mean), index score | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 1.03 | — |
| Dapagliflozin (DAPA) | 0.6 | — |
| EQW Plus DAPA | 0.91 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 0.7 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 1.1 | — |
Cardiometabolic biomarkers
4 endpointsTotal Cholesterol Levels
Time frame:24 weeks of treatment
Total cholesterol, change
change from baseline, improvement
LOINC 2093-3
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 189 | — |
| Dapagliflozin (DAPA) | 186 | — |
| EQW Plus DAPA | 185 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 192 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 178 | — |
Triglyceride (TRG) Levels
Time frame:24 weeks of treatment
Triglycerides, change
change from baseline, improvement
LOINC 2571-8
Posted result
| Group | Value (mean), mg/dL | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 130 | — |
| Dapagliflozin (DAPA) | 132 | — |
| EQW Plus DAPA | 112 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 105 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 110 | — |
Systolic Blood Pressure (SBP)
Time frame:24 weeks treatment
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 123.6 | — |
| Dapagliflozin (DAPA) | 123 | — |
| EQW Plus DAPA | 122 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 128 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 124 | — |
Diastolic Blood Pressure (DBP)
Time frame:24 weeks of treatment
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Posted result
| Group | Value (mean), mmHg | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 81 | — |
| Dapagliflozin (DAPA) | 79.8 | — |
| EQW Plus DAPA | 76 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 82 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 83.6 | — |
Other clinical outcomes
3 endpointsTotal Testosterone Concentrations
Time frame:24 weeks of treatment
Androgen, change
change from baseline, improvement
Posted result
| Group | Value (mean), ng/dL | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 38.8 | — |
| Dapagliflozin (DAPA) | 35 | — |
| EQW Plus DAPA | 42.6 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 39.5 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 45.5 | — |
Dehydroepiandrosterone Sulfate (DHEA-S) Levels
Time frame:24 weeks of treatment
Androgen, change
change from baseline, improvement
Posted result
| Group | Value (mean), mcg/dL | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 165 | — |
| Dapagliflozin (DAPA) | 187 | — |
| EQW Plus DAPA | 169 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 189 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 201 | — |
Free Androgen Index (FAI)
Time frame:24 weeks of treatment
Androgen, change
change from baseline, improvement
Posted result
| Group | Value (mean), index score | 95% CI |
|---|---|---|
| Exenatide Once Weekly (EQW ) | 5.3 | — |
| Dapagliflozin (DAPA) | 4.7 | — |
| EQW Plus DAPA | 5.2 | — |
| Dapagliflozin Plus Glucophage (MET ER) | 5.7 | — |
| Phentermine /Topiramate (PHEN/ TPM) ER | 5 | — |
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The Journal of clinical endocrinology and metabolism2021 Sep 27PMID34097062doi:10.1210/clinem/dgab408via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.