← Trials/Trial dossier/NCT02635386

CompletedPhase 3Results posted

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

Woman's

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

119

actual

Study population

Obesity / overweight, PCOS

Key I/E criteria

BMI ≥30Female

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

NCT IDNCT02635386
Org study IDRP15-008
Secondary IDAZ ESR-14-10725Astra Zeneca,L.P

Timeline

Milestones

Study first posted2015-12-18estimated
Study start2016-03-22actual
Primary completion2020-07-22actual
Study completion2020-10-09actual
Last update posted2021-01-29actual
Results first posted2021-01-29actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexFemale
Healthy volunteersAccepted

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
Glycemic / diabetes
6
Cardiometabolic biomarkers
4
Other clinical outcomes
3

Weight & body composition

10 endpoints
Secondary/protocol endpoint

Absolute Body Weight

Time frame:24 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kilogram95% CI
Exenatide Once Weekly (EQW )100.4
Dapagliflozin (DAPA)102.6
EQW Plus DAPA99
Dapagliflozin Plus Glucophage (MET ER)101.2
Phentermine /Topiramate (PHEN/ TPM) ER97
p<0.0001ANOVA
Secondary/protocol endpoint

Body Mass Index (BMI)

Time frame:24 weeks of treatment

BMI, change

change from baseline, improvement

Posted result

GroupValue (mean), kilogram/meter squared95% CI
Exenatide Once Weekly (EQW )37.3
Dapagliflozin (DAPA)37.4
EQW Plus DAPA36.7
Dapagliflozin Plus Glucophage (MET ER)37
Phentermine /Topiramate (PHEN/ TPM) ER35.3
p<0.0001ANOVA
Secondary/protocol endpoint

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

GroupValue (mean), percentage change in body weight95% CI
Exenatide Once Weekly (EQW )3.8
Dapagliflozin (DAPA)1.5
EQW Plus DAPA6.9
Dapagliflozin Plus Glucophage (MET ER)1.7
Phentermine /Topiramate (PHEN/ TPM) ER8.1
p<0.0001ANOVA

One way ANOVA with Bonferroni test to compare differences between groups if significant

Secondary/protocol endpoint

Central Adiposity (Waist Circumference)

Time frame:24 weeks of treatment

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (mean), centimeters95% CI
Exenatide Once Weekly (EQW )104
Dapagliflozin (DAPA)101
EQW Plus DAPA106
Dapagliflozin Plus Glucophage (MET ER)101.3
Phentermine /Topiramate (PHEN/ TPM) ER97
p<0.0001ANOVA
Secondary/protocol endpoint

Waist-to-Hip Ratio (WHR)

Time frame:24 weeks of treatment

ratio, improvement

Posted result

GroupValue (mean), ratio95% 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
p<0.05ANOVA
Secondary/protocol endpoint

Waist-to-Height Ratio (WHtR)

Time frame:24 weeks of treatment

ratio, improvement

Posted result

GroupValue (mean), ratio95% 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
p<0.0001ANOVA
Secondary/protocol endpoint

Total Fat Mass (kg) Evaluated by DEXA

Time frame:24 weeks of treatment

Total fat mass

change from baseline, improvement

Posted result

GroupValue (mean), kilogram95% CI
Exenatide Once Weekly (EQW )47.6
Dapagliflozin (DAPA)47.8
EQW Plus DAPA45.9
Dapagliflozin Plus Glucophage (MET ER)48
Phentermine /Topiramate (PHEN/ TPM) ER44.5
p<0.0001ANOVA
Secondary/protocol endpoint

Total Body Fat (%) by DEXA

Time frame:24 weeks of treatment

Total fat mass

change from baseline, improvement

Posted result

GroupValue (mean), percent fat mass95% CI
Exenatide Once Weekly (EQW )46.1
Dapagliflozin (DAPA)46.4
EQW Plus DAPA45.8
Dapagliflozin Plus Glucophage (MET ER)46.1
Phentermine /Topiramate (PHEN/ TPM) ER45.2
p<0.0001ANOVA
Secondary/protocol endpoint

Android-Gynoid Ratio (AGR) as Determined by DEXA

Time frame:24 weeks of treatment

change from baseline, improvement

Posted result

GroupValue (mean), ratio95% CI
Exenatide Once Weekly (EQW )1.07
Dapagliflozin (DAPA)1.02
EQW Plus DAPA1.04
Dapagliflozin Plus Glucophage (MET ER)1.04
Phentermine /Topiramate (PHEN/ TPM) ER1.03
p<0.01ANOVA
Secondary/protocol endpoint

Trunk/Leg Fat Ratio by DEXA

Time frame:24 weeks of treatment

ratio, improvement

Posted result

GroupValue (mean), ratio95% 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
p<0.035ANOVA

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

Oral Disposition (Insulin Sensitivity-insulin Secretion) Index

Time frame:24 weeks of treatment

change from baseline, improvement

Posted result

GroupValue (mean), index score95% CI
Exenatide Once Weekly (EQW )471
Dapagliflozin (DAPA)311
EQW Plus DAPA503
Dapagliflozin Plus Glucophage (MET ER)395
Phentermine /Topiramate (PHEN/ TPM) ER545
p<0.02ANOVA
Secondary/protocol endpoint

Fasting Blood Glucose

Time frame:24 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), mg/dL95% CI
Exenatide Once Weekly (EQW )91
Dapagliflozin (DAPA)93
EQW Plus DAPA86.5
Dapagliflozin Plus Glucophage (MET ER)89
Phentermine /Topiramate (PHEN/ TPM ER91.4
p<0.0001ANOVA
Secondary/protocol endpoint

OGTT Mean Blood Glucose (MBG)

Time frame:24 weeks of treatment

change from baseline, improvement

Posted result

GroupValue (mean), mg/dL95% CI
Exenatide Once Weekly (EQW )118
Dapagliflozin (DAPA)126.4
EQW Plus DAPA112
Dapagliflozin Plus Glucophage (MET ER)119
Phentermine /Topiramate (PHEN/ TPM ER113
p<0.02ANOVA
Secondary/protocol endpoint

Fasting Insulin Sensitivity (HOMA-IR)

Time frame:24 weeks of treatment

HOMA-IR (insulin sensitivity)

ratio, improvement

Posted result

GroupValue (mean), index score95% CI
Exenatide Once Weekly (EQW )3.7
Dapagliflozin (DAPA)3.6
EQW Plus DAPA2.6
Dapagliflozin Plus Glucophage (MET ER)3.3
Phentermine /Topiramate (PHEN/ TPM) ER3.4
p<0.035ANOVA
Secondary/protocol endpoint

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

GroupValue (mean), index score95% CI
Exenatide Once Weekly (EQW )3.1
Dapagliflozin (DAPA)3.6
EQW Plus DAPA3.9
Dapagliflozin Plus Glucophage (MET ER)4.8
Phentermine /Topiramate (PHEN/ TPM) ER4.7
p<0.0001ANOVA
Secondary/protocol endpoint

Corrected First Phase Insulin Secretion (IGI/HOMA-IR)

Time frame:24 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Posted result

GroupValue (mean), index score95% CI
Exenatide Once Weekly (EQW )1.03
Dapagliflozin (DAPA)0.6
EQW Plus DAPA0.91
Dapagliflozin Plus Glucophage (MET ER)0.7
Phentermine /Topiramate (PHEN/ TPM) ER1.1
p<0.04ANOVA

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

Total Cholesterol Levels

Time frame:24 weeks of treatment

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Posted result

GroupValue (mean), mg/dL95% CI
Exenatide Once Weekly (EQW )189
Dapagliflozin (DAPA)186
EQW Plus DAPA185
Dapagliflozin Plus Glucophage (MET ER)192
Phentermine /Topiramate (PHEN/ TPM) ER178
p>0.05ANOVA
Secondary/protocol endpoint

Triglyceride (TRG) Levels

Time frame:24 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

GroupValue (mean), mg/dL95% CI
Exenatide Once Weekly (EQW )130
Dapagliflozin (DAPA)132
EQW Plus DAPA112
Dapagliflozin Plus Glucophage (MET ER)105
Phentermine /Topiramate (PHEN/ TPM) ER110
p<0.04ANOVA
Secondary/protocol endpoint

Systolic Blood Pressure (SBP)

Time frame:24 weeks treatment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

GroupValue (mean), mmHg95% CI
Exenatide Once Weekly (EQW )123.6
Dapagliflozin (DAPA)123
EQW Plus DAPA122
Dapagliflozin Plus Glucophage (MET ER)128
Phentermine /Topiramate (PHEN/ TPM) ER124
p<0.035ANOVA
Secondary/protocol endpoint

Diastolic Blood Pressure (DBP)

Time frame:24 weeks of treatment

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

GroupValue (mean), mmHg95% CI
Exenatide Once Weekly (EQW )81
Dapagliflozin (DAPA)79.8
EQW Plus DAPA76
Dapagliflozin Plus Glucophage (MET ER)82
Phentermine /Topiramate (PHEN/ TPM) ER83.6
p<0.035ANOVA

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint

Total Testosterone Concentrations

Time frame:24 weeks of treatment

Androgen, change

change from baseline, improvement

Posted result

GroupValue (mean), ng/dL95% CI
Exenatide Once Weekly (EQW )38.8
Dapagliflozin (DAPA)35
EQW Plus DAPA42.6
Dapagliflozin Plus Glucophage (MET ER)39.5
Phentermine /Topiramate (PHEN/ TPM) ER45.5
p<0.0001ANOVA
Secondary/protocol endpoint

Dehydroepiandrosterone Sulfate (DHEA-S) Levels

Time frame:24 weeks of treatment

Androgen, change

change from baseline, improvement

Posted result

GroupValue (mean), mcg/dL95% CI
Exenatide Once Weekly (EQW )165
Dapagliflozin (DAPA)187
EQW Plus DAPA169
Dapagliflozin Plus Glucophage (MET ER)189
Phentermine /Topiramate (PHEN/ TPM) ER201
p<0.05ANOVA
Secondary/protocol endpoint

Free Androgen Index (FAI)

Time frame:24 weeks of treatment

Androgen, change

change from baseline, improvement

Posted result

GroupValue (mean), index score95% CI
Exenatide Once Weekly (EQW )5.3
Dapagliflozin (DAPA)4.7
EQW Plus DAPA5.2
Dapagliflozin Plus Glucophage (MET ER)5.7
Phentermine /Topiramate (PHEN/ TPM) ER5
p<0.001ANOVA

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.