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Polycystic Ovary SyndromePhase 4NCT04029272

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

A Phase 4 study testing Metformin and Exenatide 2 MG in people with Polycystic Ovary Syndrome, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Metformin and Exenatide 2 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
20 Jul 2019to 31 Dec 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Yan Deng contact

13167559763

yanndeng@163.com

Aiju Sun contact

China1 site, 1 recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 1000730

    Recruiting

Other trials in China

About this study

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

The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks. Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.

Being tested
Metformin, Exenatide 2 MG
Keywords
PCOS, GLP-1, GLP-1RA, exenatide, Metformin, glucagon-like peptide 1, glucagon-like peptide 1 receptor agonist
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

    Also called Glucophage

    500 mg tid for 12 weeks

  • Exenatide 2 MGDrug

    Also called Bydureon

    Exenatide injection once weekly for 12 weeks

Study groups in NCT04029272
Study groupRoleWhat they receive
MetforminActive comparatorBackground therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.
Receives: Drug: Metformin
Metformin+EQWExperimentalBackground therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d. EQW: Participants will receive long-acting Exenatide once a week for 12 weeks
Receives: Drug: Metformin; Drug: Exenatide 2 MG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in body weight

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

Secondary outcomes (27)

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

    Measured: 12 weeks

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

    Measured: 12 weeks

  3. Change in body mass index (BMI)

    Measured: 12 weeks

  4. Change in waist circumference(WC)

    Measured: 12 weeks

  5. Change in hip circumference (HC)

    Measured: 12 weeks

  6. Changes in lipid accumulation product(LAP)

    LAP=(WC(cm)-58)×TG (mmol/L)

    Measured: 12 weeks

  7. Changes in Visceral obesity index(VAI)

    VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))

    Measured: 12 weeks

  8. Changes in blood pressure

    Measured: 12 weeks

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

    glucose obtained at 0,30,60 and 120 minutes during the OGTT. HOMA-IR=Glu0(mmol/l)×Ins0(mU/ml)/22.5

    Matsuda index=1000/ square(Ins0 (mU/ml) ×Glu0 (mmol/l)×mean Glu(mmol/l)×meanIns(mU/ml)]

    QUICKI= 1/Log[Glu0 (mU/ml) ×Ins0 (mmol/l)]

    HOMA-β=20×Ins0 (mU/ml) /(Glu0 (mmol/l)-3.5)

    MBCI= Ins0 (mU/ml)×Glu0(mmol/l)／(Glu120(mmol/l)＋Glu60 (mmol/l)-2×Glu0 (mmol/l)）

    ΔI30/ΔG30 = (Ins30- Ins0)/( Glu30- Glu0)

    Measured: 12 weeks

  10. Changes in total cholesterol (TC)

    Measured: 12 weeks

  11. Changes in serum triglyceride (TG)

    Measured: 12 weeks

  12. Changes in high-density lipoproteincholesterol (HDL-C)

    Measured: 12 weeks

  13. Changes in low-density lipoproteincholesterol (LDL-C)

    Measured: 12 weeks

  14. Changes in lipoprotein(a)

    Measured: 12 weeks

  15. Changes in apolipoprotein a1(ApoA1)

    Measured: 12 weeks

  16. Changes in apolipoprotein B(ApoB)

    Measured: 12 weeks

  17. Changes in free fatty acid (FFA)

    Measured: 12 weeks

  18. Changes in high sensitivity C reactive protein(hsCRP)

    Measured: 12 weeks

  19. Frequency of menstrual cycle

    The number of menstrual cycles during the previous year was recorded and the menstrual cycle ratio calculated by dividing 12 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 12 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 3 by the number of menstrual cycles recorded in each patient's menstrual cycle diary.

    Measured: 12 weeks

  20. Changes in testosterone

    Measured: 12 weeks

  21. Changes in Dehydroepiandrosterone sulfate (DHEAS)

    Measured: 12 weeks

  22. Changes in Luteinizing Hormone (LH)

    Measured: 12 weeks

  23. Changes in follicle stimulating hormone(FSH)

    Measured: 12 weeks

  24. Changes in LH/FSH

    Measured: 12 weeks

  25. Changes in Acne severity score

    This system divides the face, chest, and upper back into 6 areas: the forehead, right cheek,left cheek, nose, chin, and torso (chest and upper back combined). Each acne lesion is described and scored as a comedo (1 point), papule (2 points), pustule (3 points), or nodule (4 points); absence of an acne lesion in an area results in a score of 0 points. The local score for each anatomic area is determined by multiplying the score of the most severe lesion by an area factor (1 to 3), and the local scores of the 6 areas are then added together to obtain the total score. Acne severity is graded as none (total score, 0 points), mild (total score, 1-18 points), moderate (total score, 19-30 points), severe (total score, 31-38 points), and very severe (total score N38 points)

    Measured: 12 weeks

  26. Changes in ovarian volume

    Measured: 12 weeks

  27. Changes in follicular number of 2-9mm in diameter

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2019
  2. Study start20 Jul 2019 (estimated)
  3. Primary completion28 Feb 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04029272
Sponsor's protocol ID
PCOS201907
Status last verified
Jul 2019
First submitted
8 Jul 2019
Last updated
23 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xuesong D, Tao T, Weilu W, Wei X, Wei X, Yan D, Yanfang W, Ruilin M, Yingying G, Yue W, Perez-Lopez FR, Yang W. Combined metformin and exenatide versus only metformin treatments in polycystic ovary syndrome with abdominal obesity and network pharmacology of gene expression: evidence from a randomized clinical trial. Ther Adv Endocrinol Metab. 2025 Aug 19;16:20420188251355411. doi: 10.1177/20420188251355411. eCollection 2025.

    PubMed 40843067

  • Ma RL, Deng Y, Wang YF, Zhu SY, Ding XS, Sun AJ. Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome. Chin Med J (Engl). 2021 Nov 3;134(23):2882-2889. doi: 10.1097/CM9.0000000000001712.

    PubMed 34732660

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin and Exenatide 2 MG in people with Polycystic Ovary Syndrome, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yan Deng (13167559763, yanndeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in body weight (time frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04029272, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.

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