DelfaGLP-1 Atlas

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UnknownPhase 4

Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients

Study on the Effect of Metformin vs Metformin Combined With GLP-1 RA (Exenatide) on Overweight/Obese Patients With Polycystic Ovary Syndrome (PCOS)

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

80

estimated

Study population

Obesity / overweight, PCOS

Key I/E criteria

•BMI ≥25•Female

Primary endpoint

•Body weight, absolute change (kg)

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 IDNCT04029272
Org study IDPCOS201907

Timeline

Milestones

Study start2019-07-20estimated
Study first posted2019-07-23actual
Last update posted2019-07-23actual
Primary completion2020-02-28estimated
Study completion2020-12-31estimated

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•Females 18 years to 40 years of age
•Diagnosed as PCOS by the 2003 Rotterdam criteria.
•Overweight/obesity (BMI≥25 kg/m2)
•No pregnant plan in recent 6 months
•Written consent for participation in the study

Exclusion criteria

•type 1 or type 2 diabetes mellitus
•Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
•Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
•Serious systemic disease or malignant tumor
•History of pancreatitis (chronic, acute or recurrent)
•Body weight change ≥10% at 3 months before treatment
•Used oral contraceptives or sex hormone drugs in the past 1 month
•Used oral glucocorticoids in the past 1 month
•Substance (alcohol or drug) abuse or dependence within 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
•Subjects have a severe systemic disease, such as cardiovascular system
•Renal impairment, eGFR<60ml/min/1.73m2
•Increase of transaminases up to < 2.5 times of upper limit of normal value
•Have a history of thromboembolic disease or thrombotic tendency
•Subjects in pregnant or lactating or within 1 year after delivery.
•Subjects have an allergic history to the drugs used in the study
•Subjects have participated in other clinical researches of medicine within 1 month prior to randomization.
•Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening.

Endpoints (28)

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

Cardiometabolic biomarkers
11
Other clinical outcomes
9
Weight & body composition
7
Glycemic / diabetes
1

Weight & body composition

7 endpoints
Primary/protocol endpoint

Change in body weight

Time frame:Patient's body weight was measured at the baseline and after 12 weeks of clinical trial

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects who lost ≥5% of their body weight

Time frame:12 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects who lost ≥ 10% of their body weight

Time frame:12 weeks

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in body mass index (BMI)

Time frame:12 weeks

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist circumference(WC)

Time frame:12 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in hip circumference (HC)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in Visceral obesity index(VAI)

Time frame:12 weeks

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)

Time frame:12 weeks

Postprandial glucose

change from baseline, improvement

Cardiometabolic biomarkers

11 endpoints
Secondary/protocol endpoint

Changes in lipid accumulation product(LAP)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in blood pressure

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in total cholesterol (TC)

Time frame:12 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Changes in serum triglyceride (TG)

Time frame:12 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Changes in high-density lipoproteincholesterol (HDL-C)

Time frame:12 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Changes in low-density lipoproteincholesterol (LDL-C)

Time frame:12 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Changes in lipoprotein(a)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in apolipoprotein a1(ApoA1)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in apolipoprotein B(ApoB)

Time frame:12 weeks

ApoB, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in free fatty acid (FFA)

Time frame:12 weeks

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in high sensitivity C reactive protein(hsCRP)

Time frame:12 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Other clinical outcomes

9 endpoints
Secondary/protocol endpoint

Frequency of menstrual cycle

Time frame:12 weeks

Menstrual cyclicity

change from baseline, improvement

Secondary/protocol endpoint

Changes in testosterone

Time frame:12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in Dehydroepiandrosterone sulfate (DHEAS)

Time frame:12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in Luteinizing Hormone (LH)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in follicle stimulating hormone(FSH)

Time frame:12 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Changes in LH/FSH

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in Acne severity score

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in ovarian volume

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in follicular number of 2-9mm in diameter

Time frame:12 weeks

change from baseline, improvement

Publications (2)

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 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.