← Trials/Trial dossier/NCT04969627

CompletedPhase 4

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

Bing He

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

60

actual

Study population

Obesity / overweight, PCOS

Key I/E criteria

BMI ≥24Female

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 IDNCT04969627
Org study ID2020PS624K

Timeline

Milestones

Study start2021-01-04actual
Study first posted2021-07-21actual
Primary completion2022-01-04actual
Study completion2022-03-29actual
Last update posted2022-04-14actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexFemale
Healthy volunteersNot accepted

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

Other clinical outcomes
13
Weight & body composition
3
Glycemic / diabetes
1
Other (unclassified)
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Change in body weight

Time frame:12 weeks

Body weight, absolute change (kg)

change from baseline, 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

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint/low confidence

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

Time frame:12 weeks

change from baseline, improvement

Other clinical outcomes

13 endpoints
Secondary/protocol endpoint

Change in Ferriman-Gallwey score

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Acne severity score

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in frequency of menstrual cycle

Time frame:12 weeks

Menstrual cyclicity

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, improvement

Secondary/protocol endpoint

Changes in LH/FSH

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in progesterone (Prog)

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in total testosterone (TT)

Time frame:12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in free testosterone (FT)

Time frame:12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in free androgen index (FAI)

Time frame:12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Changes in sex hormone binding globulin (SHBG)

Time frame:12 weeks

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 anti-müllerian hormone (AMH)

Time frame:12 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Changes in prolactin (PRL)

Time frame:12 weeks

change from baseline, improvement

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.