GLP-1 Peptide Atlas, by Delfa

CompletedPhase 4

Research of Exenatide for Overweight/Obese PCOS Patients With IGR

Research of Exenatide for Management of Reproductive and Metabolic Dysfunction in Overweight/Obese PCOS Patients With Impaired Glucose Regulation

Lead sponsor

RenJi Hospital

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

183

actual

Study population

Obesity / overweight, PCOS, Prediabetes / glucose intolerance

Key I/E criterion

•Female

Primary endpoint

•Improvement of intravenous blood glucose from impaired glucose regulation

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 IDNCT03352869

Org study ID[2017]077

Timeline

Milestones

Study first posted2017-11-24actual

Study start2017-11-28actual

Primary completion2018-07-01actual

Study completion2018-07-31actual

Last update posted2019-09-11actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightPCOSPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

1. have PCOS which is diagnosed according to 2003 Rotterdam criteria;

2. overweight / obesity diagnostic criteria is based on WHO-WPR ;

3. IGR diagnostic criteria is based on 1999 WHO diagnostic criteria;

4. have been treated with dietary and behavioral intervention for 3 months but are ineffective;

5. have no use of other hypoglycemic drugs before 3 months of treatment.

Exclusion criteria

•Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months)

•high blood pressure (>160/100mmHg)

•active infection

•secondary diabetes

•pregnancy

•alcohol abuse

•allergic to GLP-1 receptor agonist or metformin

Endpoints (4)

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

Glycemic / diabetes

MASH / liver

Cardiometabolic biomarkers

Other clinical outcomes

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation

Time frame:up to 12 weeks

categorical status, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint

Improvement of fatty liver

Time frame:up to 12 weeks

categorical status, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Improvement of blood lipid

Time frame:up to 12 weeks

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Improvement of hyperandrogenism

Time frame:up to 12 weeks

Androgen, change

change from baseline, improvement

Publications (8)

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

Exenatide, Metformin, or Both for Prediabetes in PCOS: A Randomized, Open-label, Parallel-group Controlled Study.
The Journal of clinical endocrinology and metabolism2021 Mar 8PMID32995892doi:10.1210/clinem/dgaa692via clinicaltrials gov reference derived + pubmed nct search
Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.
BMC endocrine disorders2017 Jan 31PMID28143456doi:10.1186/s12902-017-0155-9via CT.gov reference
The effects of treatment with liraglutide on atherothrombotic risk in obese young women with polycystic ovary syndrome and controls.
BMC endocrine disorders2015 Apr 2PMID25880805doi:10.1186/s12902-015-0005-6via CT.gov background
Off-label drug use in the treatment of polycystic ovary syndrome.
Fertility and sterility2015 Mar (month)PMID25726702doi:10.1016/j.fertnstert.2015.01.019via CT.gov background
Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome.
Endocrine research2015 (year)PMID25330463doi:10.3109/07435800.2014.966385via CT.gov background
Glucagon-like peptide-1 analogue, liraglutide, improves liver fibrosis markers in obese women with polycystic ovary syndrome and nonalcoholic fatty liver disease.
Clinical endocrinology2014 Oct (month)PMID24256515doi:10.1111/cen.12369via CT.gov background
Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.
European journal of endocrinology2014 Mar (month)PMID24362411doi:10.1530/EJE-13-0797via CT.gov background
Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.
The Journal of clinical endocrinology and metabolism2008 Jul (month)PMID18460557doi:10.1210/jc.2008-0115via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.