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Effects of GLP-1 Analogue Combined With Metformin and Metformin on Gonadal and Metabolic Profiles in Chinese Overweight/Obese PCOS Patients With Hyperandrogenemia.
Lead sponsor
Asset
Exenatide
GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
60
actual
Study population
Obesity / overweight, PCOS
Key I/E criteria
•BMI ≥24•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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Females 18 years to 40 years of age Diagnosed as PCOS by the 2003 Rotterdam criteria
2. Overweight/obesity (BMI≥24 kg/m2)
3. No pregnant plan in recent 6 months
4. Written consent for participation in the study
Exclusion criteria
1. type 1 or type 2 diabetes mellitus
2. Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
3. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
4. Serious systemic disease or malignant tumor
5. History of pancreatitis (chronic, acute or recurrent)
6. Body weight change ≥10% at 3 months before treatment
7. Used oral contraceptives or sex hormone drugs in the past 1 month
8. Used oral glucocorticoids in the past 1 month
9. Substance (alcohol or drug) abuse or dependence within 3 months
10. Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (>10g/d)
11. Subjects have a severe systemic disease, such as cardiovascular system, Renal impairment (eGFR<60ml/min/1.73m2)
12. Increase of transaminases up to < 2.5 times of upper limit of normal value
13. Have a history of thromboembolic disease or thrombotic tendency
14. Subjects in pregnant or lactating or within 1 year after delivery
15. Subjects have an allergic history to the drugs used in the study
16. Subjects have participated in other clinical researches of medicine within 1 month prior to randomization
17. Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening
Endpoints (18)
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
3 endpointsChange in body weight
Time frame:12 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Change in body mass index (BMI)
Time frame:12 weeks
BMI, change
change from baseline, improvement
Change in waist circumference(WC)
Time frame:12 weeks
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
1 endpointChanges in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
Time frame:12 weeks
change from baseline, improvement
Other clinical outcomes
13 endpointsChange in Ferriman-Gallwey score
Time frame:12 weeks
change from baseline, improvement
Change in Acne severity score
Time frame:12 weeks
change from baseline, improvement
Changes in frequency of menstrual cycle
Time frame:12 weeks
Menstrual cyclicity
change from baseline, improvement
Changes in Luteinizing Hormone (LH)
Time frame:12 weeks
change from baseline, improvement
Changes in follicle stimulating hormone (FSH)
Time frame:12 weeks
change from baseline, improvement
Changes in LH/FSH
Time frame:12 weeks
change from baseline, improvement
Changes in progesterone (Prog)
Time frame:12 weeks
change from baseline, improvement
Changes in total testosterone (TT)
Time frame:12 weeks
Androgen, change
change from baseline, improvement
Changes in free testosterone (FT)
Time frame:12 weeks
Androgen, change
change from baseline, improvement
Changes in free androgen index (FAI)
Time frame:12 weeks
Androgen, change
change from baseline, improvement
Changes in sex hormone binding globulin (SHBG)
Time frame:12 weeks
change from baseline, improvement
Changes in dehydroepiandrosterone sulfate (DHEAS)
Time frame:12 weeks
Androgen, change
change from baseline, improvement
Changes in anti-müllerian hormone (AMH)
Time frame:12 weeks
change from baseline, improvement
Other (unclassified)
1 endpointChanges in prolactin (PRL)
Time frame:12 weeks
change from baseline, improvement
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.