GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4Results posted

The Effect of GLP-1 Agonists Versus OCs on Reproductive Disorders and Cardiovascular Risks in Overweight PCOS

Randomized Clinical Trial to Evaluate The Effect of Metformin-GLP-1 Receptor Agonist Versus Oral Contraceptive (OC) Therapy on Reproductive Disorders and Cardiovascular Risks in Overweight Polycystic Ovarian Syndrome (PCOS) Patients

Lead sponsor

Xinqiao Hospital of Chongqing

Assets

Exenatide / GLP-1 / incretin class catch-all / Liraglutide

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, PCOS

Key I/E criteria

•BMI ≥24•Female

Primary endpoint

•Assessment of Reproductive Functions

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 IDNCT03151005

Org study IDXinqiao Endocrinology

Timeline

Milestones

Study first posted2017-05-12actual

Study start2017-07-01actual

Primary completion2021-04-01actual

Study completion2021-04-23actual

Last update posted2023-12-04actual

Results first posted2023-12-04actual

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all Liraglutide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years

Maximum age50 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Clinical diagnosis of PCOS according to the Rotterdam criteria based on the presence of two of three criteria: oligomenorrhoea, clinical or biochemical hyperandrogenism and polycystic ovaries on ultrasound after exclusion of other endocrine causes of hyperandrogenism.

•Participants had no concurrent illness and were not on any prescription or over-the-counter medication that was likely to affect insulin sensitivity or lipids for the preceding 12 weeks.

•Participants were advised not to change physical activity or dietary habits during the study period. All subjects were overweight/obese [body mass index (BMI) >=24 kg/m2 or waistline>=85cm ].

•All subjects had normal thyroid-stimulating hormone and prolactin levels.

Exclusion criteria

•smoking, alcohol use, or having taken medication within 2 months of the study that is known to affect reproductive or metabolic functions.

•age below 18 yr or over 50 yr.

•postmenopausal.

•uncontrolled hypertension (blood pressure >=160/100 mm Hg).

•preexisting OPs or GLP-1 agonists supplementation

•alcohol intake greater than 20 g/d, or pregnancy.

•signs of liver or renal failure or active liver disease (ALT > 2.5× the upper limit of normal values).

•PLT<60*10^9/L,Hb<100g/L, smoking, alcohol use.

•The patient that cannot complete the intervention or have other conditions that is not appropriate to enter the group, such as patients who are taking glucocorticoid steroids or malignant tumor treatment, etc.

Endpoints (10)

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

Other clinical outcomes

Weight & body composition

MASH / liver

Cardiometabolic biomarkers

Weight & body composition

2 endpoints

Secondary/registry result

Basic Vital Signs

Time frame:12 weeks

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kg/m^2	95% CI
Metformin-GLP-1 Receptor Agonist	26.26	—
Metformin-Oral Contraceptive(OC)	27.12	—

Secondary/protocol endpoint

Basic Vital Signs

Time frame:12 weeks

BMI, change

change from baseline, improvement

MASH / liver

2 endpoints

Secondary/registry result

Assessment of Liver Function

Time frame:12 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Posted result

Group	Value (mean), IU/L	95% CI
Metformin-GLP-1 Receptor Agonist	39.09	—
Metformin-Oral Contraceptive(OC)	36.73	—

Secondary/protocol endpoint

Assessment of Liver Function

Time frame:12 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Cardiometabolic biomarkers

2 endpoints

Secondary/registry result

Assessment of Blood Pressure

Time frame:12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), mmHg	95% CI
Metformin-GLP-1 Receptor Agonist	122.83	—
Metformin-Oral Contraceptive(OC)	122.40	—

Secondary/protocol endpoint

Assessment of Blood Pressure

Time frame:12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Other clinical outcomes

4 endpoints

Primary/registry result

Assessment of Reproductive Functions

Time frame:12 weeks

concentration, descriptive

Posted result

Group	Value (mean), mIU/ml	95% CI
Metformin-GLP-1 Receptor Agonist	5.52	—
Metformin-Oral Contraceptive(OC)	5.33	—

Primary/protocol endpoint

Assessment of Reproductive Functions

Time frame:12 weeks

concentration, descriptive

Secondary/registry result

Assessment of Reproductive Function

Time frame:12 weeks

Androgen, change

change from baseline, improvement

Posted result

Group	Value (mean), nmol/L	95% CI
Metformin-GLP-1 Receptor Agonist	1.82	—
Metformin-Oral Contraceptive(OC)	2.14	—

Secondary/protocol endpoint

Assessment of Reproductive Function

Time frame:12 weeks

Androgen, change

change from baseline, improvement

Publications (12)

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

Effects and plasma proteomic analysis of GLP-1RA versus CPA/EE, in combination with metformin, on overweight PCOS women: a randomized controlled trial.
Endocrine2024 Jan (month)PMID37653215doi:10.1007/s12020-023-03487-4via clinicaltrials gov reference derived + pubmed nct search
Polycystic ovary syndrome: definition, aetiology, diagnosis and treatment.
Nature reviews. Endocrinology2018 May (month)PMID29569621doi:10.1038/nrendo.2018.24via CT.gov reference
GLP-1 Improves Adipocyte Insulin Sensitivity Following Induction of Endoplasmic Reticulum Stress.
Frontiers in pharmacology2018 (year)PMID30459598doi:10.3389/fphar.2018.01168via CT.gov reference
Insulin and the polycystic ovary syndrome.
Diabetes research and clinical practice2017 Aug (month)PMID28646699doi:10.1016/j.diabres.2017.06.011via CT.gov reference
Use of cyproterone acetate/ethinylestradiol in polycystic ovary syndrome: rationale and practical aspects.
The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception2017 Jun (month)PMID28463030doi:10.1080/13625187.2017.1317735via CT.gov reference
Metformin: a review of its potential indications.
Drug design, development and therapy2017 (year)PMID28860713doi:10.2147/DDDT.S141675via CT.gov reference
Scientific Statement on the Diagnostic Criteria, Epidemiology, Pathophysiology, and Molecular Genetics of Polycystic Ovary Syndrome.
Endocrine reviews2015 Oct (month)PMID26426951doi:10.1210/er.2015-1018via CT.gov reference
Polycystic ovary syndrome: current status and future perspective.
Frontiers in bioscience (Elite edition)2014 Jan 1PMID24389146doi:10.2741/e695via CT.gov reference
Prevalence, phenotype and cardiometabolic risk of polycystic ovary syndrome under different diagnostic criteria.
Human reproduction (Oxford, England)2012 Oct (month)PMID22777527doi:10.1093/humrep/des232via CT.gov reference
Insulin resistance, obesity, inflammation, and depression in polycystic ovary syndrome: biobehavioral mechanisms and interventions.
Fertility and sterility2010 Oct (month)PMID20471009doi:10.1016/j.fertnstert.2010.03.081via CT.gov reference
Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS).
Human reproduction (Oxford, England)2004 Jan (month)PMID14688154doi:10.1093/humrep/deh098via CT.gov reference
Predictive values of body mass index and waist circumference for risk factors of certain related diseases in Chinese adults--study on optimal cut-off points of body mass index and waist circumference in Chinese adults.
Biomedical and environmental sciences : BES2002 Mar (month)PMID12046553via CT.gov reference

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.