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PCOS (Polycystic Ovary Syndrome)Phase 4NCT05702905

Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome

A Phase 4 study testing Metformin Hydrochloride 500 MG, Semaglutide, 1.34 mg/mL and Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG in people with PCOS (Polycystic Ovary Syndrome) and Semaglutide, run by Peking University First 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. Read more about this study

Who is it for?
Ages 22 to 40 years, women only
Conditions the study is for
PCOS (Polycystic Ovary Syndrome), Semaglutide
What is being tested?
Metformin Hydrochloride 500 MG, Semaglutide, 1.34 mg/mL and Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChina
Study dates
9 May 2023to 30 Jun 2025
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 22 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Meet the PCOS diagnostic criteria (Rotterdam）
  • Age 22-40
  • BMI ≥ 28 kg/m2
  • Infertility: having normal sexual life and failing to conceive without contraception for more than 1 year
  • Willing to be pregnant, and her husband has no serious infertility

Who cannot join

  • History of acute pancreatitis, individual or family history of medullary thyroid cancer and multiple endocrine adenomas
  • Type 1 diabetes and special type diabetes
  • History of tumor
  • Serious cardiovascular and cerebrovascular disease, mental disease, liver or kidney disease
  • Metformin, GLP-1 RA and other drugs affecting reproductive and metabolic functions were used within 90 days before the study
  • Known allergy to metformin, GLP-1 RA and excipients
Show all 9Show fewer
  • Severe endometriosis, low ovarian reserve, premature ovarian failure
  • Inability to tolerate pregnancy and ovulation induction therapy
  • Other conditions considered unsuitable for this study by researchers

Trial locations and contacts

1 site in 1 country.

Tingting Zhang, M.D. contact

86-10-83575103

cathine@sina.com

China1 site, 1 recruiting

  • PekingUFH

    Beijing, Beijing Municipality, 100034

    Tingtiing Zhang, MD, 86-10-13691415781, cathine@sina.com

    Recruiting

Other trials in China

About this study

Official title: Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic Ovary Syndrome: a Prospective, Randomized, Open, Controlled Study

To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. All subjects will be treated for 12 weeks, and then stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks for pregnancy outcome. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.

Read the detailed description

To investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. Metformin and semaglutide will be administered in a dose increasing mode, and then maintain until the end of 12 weeks, and metabolic related indexes will be evaluated. After 12 weeks of treatment, all subjects will stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks to evaluate the fertility related indicators. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.

Being tested
Metformin Hydrochloride 500 MG, Semaglutide, 1.34 mg/mL, Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG, calorie-restricted diet, physical exercise
Keywords
PCOS, semaglutide, obese, metabolic abnormality, fertility
Medical subject headings
Polycystic Ovary Syndrome, Obesity

What participants receive

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

  • Metformin Hydrochloride 500 MGDrug

    Also called Glucophage

    Metformin oral tablet (500mg per tablet) will be administered in a dose increasing mode: the initial dose will be 500mg twice daily, which will be increased to 1000mg twice daily after two weeks, and then maintained until the end of treatment in total 12 weeks.

  • Semaglutide, 1.34 mg/mLDrug

    Also called WEGOVY

    Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and increased to 1.0mg QW after another 4 weeks, and then maintained 1.0mg until the end of treatment in total 12 weeks.

  • Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MGDrug

    Also called WEGOVY and Glucophage

    Both Semaglutide injection and Metformin oral tablet will be administered as described above.

  • calorie-restricted dietBehavioural

    All subjects after randomization will be reviewed and evaluated by a nutritionist, and then will receive diet guidance. The clinical nutritionist will develop a written nutrition plan for each subject. The nutrition plan of this study adopted the method of calorie restriction diet (CRD) to develop a diet, which required 83.68 kJ/kg of energy per day, 1.2 g/kg of protein per day, 40%~55% of carbohydrate energy supply ratio, and 20%~30% of fat energy supply ratio, to ensure the intake of vegetables, fruits and other rich dietary fiber, and drinking more than 1.5 L per day. The nutritionist will explain the method of food exchange in detail to enrich the food types of patients. The diet diary will be distributed to each subject, and the subjects will be required to make a return visit once every four weeks, return the diet diary each time, and receive guidance according to their compliance.

  • physical exerciseBehavioural

    All subjects after randomization will be reviewed and evaluated by a trainer, and then will receive guidance of physical exercise.The trainer will formulate an exercise plan for each subject. The exercise plan consists of 30 minutes of moderate and low intensity continuous aerobic exercise every day, with a frequency of 5-7 days/week. The form of exercise can be determined according to personal hobbies, such as fast walking, jogging, climbing, swimming, etc. The exercise diary will be distributed to each subject, and the subjects are required to make a return visit once every four weeks, return the exercise diary each time, and the trainer will provide guidance to the subjects according to their compliance.

Study groups in NCT05702905
Study groupRoleWhat they receive
metforminActive comparatorAbout 25 subjects will be allocated to this group to receive metformin only, as the active comparator of semaglutide groups. Metformin used in this trial is Glucophage ( 500mg per tablet）produced by Bristol-Myers Squibb.The initial dose of metformin will be 500mg twice daily, which will be increased to 1000mg twice daily after two weeks, and then maintained until the end of treatment in total 12 weeks.
Receives: Drug: Metformin Hydrochloride 500 MG; Behavioral: calorie-restricted diet; Behavioral: physical exercise
semaglutideExperimentalAbout 25 subjects will be allocated to this group to receive semaglutide only, as one of the experimental groups. Semaglutide used in this trial is WEGOVY (semaglutide) injection produced by Novo Nordisk. Administer WEGOVY once weekly, on the same day each week, at any time of day, with or without meals. Inject subcutaneously in the abdomen, thigh or upper arm. Initiate at 0.25 mg once weekly for 4 weeks. In 4 week intervals, increase the dose until a dose of 1.0 mg is reached, and then maintained 1.0 mg until the end of treatment in total 12 weeks..
Receives: Drug: Semaglutide, 1.34 mg/mL; Behavioral: calorie-restricted diet; Behavioral: physical exercise
semaglutide and metforminExperimentalAbout 25 subjects will be allocated to this group to receive both semaglutide and metformin, as another of the experimental groups. Metformin used in this trial is Glucophage ( 500mg per tablet）produced by Bristol-Myers Squibb.The initial dose of metformin will be 500mg twice daily, which will be increased to 1000mg twice daily after two weeks, and then maintained until the end of treatment in total 12 weeks. Semaglutide used in this trial is WEGOVY (semaglutide) injection produced by Novo Nordisk. Administer WEGOVY once weekly, on the same day each week, at any time of day, with or without meals. Inject subcutaneously in the abdomen, thigh or upper arm. Initiate at 0.25 mg once weekly for 4 weeks. In 4 week intervals, increase the dose until a dose of 1.0 mg is reached, and then maintained 1.0 mg until the end of treatment in total 12 weeks.
Receives: Drug: Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG; Behavioral: calorie-restricted diet; Behavioral: physical exercise

What is being measured

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

  1. Percentage change in bodyweight at 12 weeks for semaglutide versus metformin

    Difference between body weight at 12 weeks and baseline divided by baseline body weight

    Measured: at the end of 12 weeks of treatment

  2. Achievement of weight reduction of at least 5% at 12 weeks for semaglutide versus metformin

    Proportion of patients with weight loss at least 5% at 12 weeks of treatment

    Measured: at the end of 12 weeks of treatment

Secondary outcomes (4)

  1. HOMA-IR at 12 weeks of treatment

    compare HOMA-IR at 12 weeks of treatment among three groups

    Measured: at the end of 12 weeks of treatment

  2. testosterone level at 12 weeks of treatment

    compare testosterone level at 12 weeks of treatment among three groups

    Measured: at the end of 12 weeks of treatment

  3. androstenedione level at 12 weeks of treatment

    compare androstenedione level at 12 weeks of treatment among three groups

    Measured: at the end of 12 weeks of treatment

  4. FAI (Free Androgen Index) at 12 weeks of treatment

    compare FAI at 12 weeks of treatment among three groups

    Measured: at the end of 12 weeks of treatment

Timeline

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

  1. First posted27 Jan 2023
  2. Study start9 May 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Jun 2025 (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
Model description
All subjects will be randomized into three groups: metformin single, semaglutide single, both metformin and semaglutide.
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05702905
Sponsor's protocol ID
2022CR04
Status last verified
Mar 2024
First submitted
23 Dec 2022
Last updated
25 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jensterle Sever M, Kocjan T, Pfeifer M, Kravos NA, Janez A. 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. Eur J Endocrinol. 2014 Feb 7;170(3):451-9. doi: 10.1530/EJE-13-0797. Print 2014 Mar.

    PubMed 24362411

  • Jensterle M, Kravos NA, Pfeifer M, Kocjan T, Janez A. A 12-week treatment with the long-acting glucagon-like peptide 1 receptor agonist liraglutide leads to significant weight loss in a subset of obese women with newly diagnosed polycystic ovary syndrome. Hormones (Athens). 2015 Jan-Mar;14(1):81-90. doi: 10.1007/BF03401383.

    PubMed 25885106

  • Salamun V, Jensterle M, Janez A, Vrtacnik Bokal E. Liraglutide increases IVF pregnancy rates in obese PCOS women with poor response to first-line reproductive treatments: a pilot randomized study. Eur J Endocrinol. 2018 Jul;179(1):1-11. doi: 10.1530/EJE-18-0175. Epub 2018 Apr 27.

    PubMed 29703793

  • Han Y, Li Y, He B. GLP-1 receptor agonists versus metformin in PCOS: a systematic review and meta-analysis. Reprod Biomed Online. 2019 Aug;39(2):332-342. doi: 10.1016/j.rbmo.2019.04.017. Epub 2019 Apr 25.

    PubMed 31229399

  • Cena H, Chiovato L, Nappi RE. Obesity, Polycystic Ovary Syndrome, and Infertility: A New Avenue for GLP-1 Receptor Agonists. J Clin Endocrinol Metab. 2020 Aug 1;105(8):e2695-709. doi: 10.1210/clinem/dgaa285.

    PubMed 32442310

  • Xing C, Zhao H, Zhang J, He B. Effect of metformin versus metformin plus liraglutide on gonadal and metabolic profiles in overweight patients with polycystic ovary syndrome. Front Endocrinol (Lausanne). 2022 Aug 17;13:945609. doi: 10.3389/fendo.2022.945609. eCollection 2022.

    PubMed 36060969

  • Papaetis GS, Kyriacou A. GLP-1 receptor agonists, polycystic ovary syndrome and reproductive dysfunction: Current research and future horizons. Adv Clin Exp Med. 2022 Nov;31(11):1265-1274. doi: 10.17219/acem/151695.

    PubMed 35951627

  • Ge JJ, Wang DJ, Song W, Shen SM, Ge WH. The effectiveness and safety of liraglutide in treating overweight/obese patients with polycystic ovary syndrome: a meta-analysis. J Endocrinol Invest. 2022 Feb;45(2):261-273. doi: 10.1007/s40618-021-01666-6. Epub 2021 Aug 29.

    PubMed 34455568

  • Liu X, Zhang Y, Zheng SY, Lin R, Xie YJ, Chen H, Zheng YX, Liu E, Chen L, Yan JH, Xu W, Mai TT, Gong Y. Efficacy of exenatide on weight loss, metabolic parameters and pregnancy in overweight/obese polycystic ovary syndrome. Clin Endocrinol (Oxf). 2017 Dec;87(6):767-774. doi: 10.1111/cen.13454. Epub 2017 Sep 13.

    PubMed 28834553

  • 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

  • Li R, Mai T, Zheng S, Zhang Y. Effect of metformin and exenatide on pregnancy rate and pregnancy outcomes in overweight or obese infertility PCOS women: long-term follow-up of an RCT. Arch Gynecol Obstet. 2022 Nov;306(5):1711-1721. doi: 10.1007/s00404-022-06700-3. Epub 2022 Jul 13.

    PubMed 35829765

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin Hydrochloride 500 MG, Semaglutide, 1.34 mg/mL and Semaglutide, 1.34 mg/mL and Metformin Hydrochloride 500 MG in people with PCOS (Polycystic Ovary Syndrome) and Semaglutide, run by Peking University First 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 9 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 25 Mar 2024. 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 Tingting Zhang, M.D. (86-10-83575103, cathine@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in bodyweight at 12 weeks for semaglutide versus metformin (time frame: at the end of 12 weeks of treatment). The study lists 2 primary outcomes in all. 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 NCT05702905, which also lists 11 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 25 Mar 2024.

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