Polycystic Ovary SyndromeNCT06775093
Effects of GLP-1RAs on Reproductive Outcomes in PCOS and Obesity
A study testing GLP-1 receptor agonist, Metformin and healthy lifestyle education in people with Polycystic Ovary Syndrome and Obesity, run by Peking University Third Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity, Infertility, Female
- What is being tested?
- GLP-1 receptor agonist, Metformin and healthy lifestyle education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI<35kg/m2;
Who cannot join
- Women with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
wangzhengmedicine@163.com
About this study
Official title: Effects of GLP-1 Receptor Agonists Combined with Metformin and Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Women with PCOS and Obesity
The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.
Read the detailed description
Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.
- Conditions
- Polycystic Ovary Syndrome, Obesity, Infertility, Female
- Being tested
- GLP-1 receptor agonist, Metformin, healthy lifestyle education
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 receptor agonistDrug
Also called Benaglutide
3 months
MetforminDrug
3 months
healthy lifestyle educationBehavioural
3 months
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 RAs combined with metformin and healthy lifestyle education | Experimental | Benaglutide injection (Fisuomei®, National Medicine Standard No. S20230042, Shanghai Renhui Biopharmaceutical Co., Ltd.) was administered at an initial dose of 0.06 mg per injection, three times daily, via subcutaneous injection 5 minutes before meals. After establishing tolerance, the dose was increased weekly by 0.04 mg per injection, reaching 0.2 mg per injection after four weeks, administered three times daily for a total of 12 weeks. Metformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was prescribed at a dose of 0.5 g twice daily for 12 weeks, taken with meals. After 12 weeks of treatment or achieving a 10% reduction in baseline body weight, the medications were discontinued. Patients were advised to maintain a healthy diet and engage in appropriate physical activity. Assisted pregnancy treatments were initiated 4 weeks after completing the weight loss phase. Receives: Drug: GLP-1 receptor agonist; Drug: Metformin; Behavioral: healthy lifestyle education |
| metformin and healthy lifestyle education | Active comparator | Metformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was administered at a dose of 0.5 g twice daily for 12 weeks, taken with meals. After 12 weeks of treatment or achieving a 10% reduction in baseline body weight, the medication was discontinued. Patients were instructed to maintain a healthy diet and engage in appropriate physical activity. Assisted pregnancy treatment was initiated 4 weeks after completing the weight loss phase. Receives: Drug: Metformin; Behavioral: healthy lifestyle education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: 18 months
Secondary outcomes (12)
BMI change from baseline to the 3rd month in kg/m2
Measured: 3 months
Spontaneous resumption of ovulation
Measured: 3 months
Clinical pregnancy
Measured: 9 months
Ongoing pregnancy
Measured: 11 months
Pregnancy loss
Measured: 18 months
Gestational age at delivery
Measured: 18 months
Time to pregnancy leading to live birth
Measured: 18 months
Hypertensive disorders of pregnancy
Measured: 18 months
Gestational diabetes
Measured: 18 months
Birth weight in kg
Measured: 18 months
Neonatal mortality
Measured: 18 months
Major congenital anomaly
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Qiao, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775093
- Sponsor's protocol ID
- M2024472
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1 Receptor Agonists Combined with Metformin and Healthy Lifestyle Education Prior to Fertility Treatment on Reproductive Outcomes in Women with PCOS and Obesity
- ClinicalTrials.gov ID
- NCT06775093
- Acronym / sponsor ID
- M2024472
- Conditions
- Polycystic Ovary Syndrome, Obesity, Infertility, Female
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to examine whether benalutide combined with metformin and healthy lifestyle education in women with PCOS and obesity prior to fertility treatment improves live birth rate and other reproductive, maternal and perinatal outcomes compared to metformin plus healthy lifestyle education.
Detailed description
Benalutide, a short-acting recombinant human GLP-1RAs with nearly 100% homology to human GLP-1, has been approved by the Chinese National Medical Products Administration for treating weight loss in individuals with obesity. Up to now, there is a paucity of research on the potential impact of GLP-1RAs on reproductive, maternal and perinatal outcomes in women with PCOS and obesity undergoing fertility treatment. Given its effectiveness as a weight loss medication, benalutide theoretically holds promise for enhancing reproductive outcomes in women with PCOS and obesity prior to fertility treatment by facilitating weight reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 RAs combined with metformin and healthy lifestyle education | Experimental | Drug: GLP-1 receptor agonist, Drug: Metformin, Behavioral: healthy lifestyle educationBenaglutide injection (Fisuomei®, National Medicine Standard No. S20230042, Shanghai Renhui Biopharmaceutical Co., Ltd.) was administered at an initial dose of 0.06 mg per injection, three times daily, via subcutaneous injection 5 minutes before meals. After establishing tolerance, the dose was increased weekly by 0.04 mg per injection, reaching 0.2 mg per injection after four weeks, administered three times daily for a total of 12 weeks. Metformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was prescribed at a dose of 0.5 g twice daily for 12 weeks, taken with meals. After 12 weeks of treatment or achieving a 10% reduction in baseline body weight, the medications were discontinued. Patients were advised to maintain a healthy diet and engage in appropriate physical activity. Assisted pregnancy treatments were initiated 4 weeks after completing the weight loss phase. |
| metformin and healthy lifestyle education | Active comparator | Drug: Metformin, Behavioral: healthy lifestyle educationMetformin hydrochloride (Glucophage®, National Medicine Standard No. H20023370, Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd.) was administered at a dose of 0.5 g twice daily for 12 weeks, taken with meals. After 12 weeks of treatment or achieving a 10% reduction in baseline body weight, the medication was discontinued. Patients were instructed to maintain a healthy diet and engage in appropriate physical activity. Assisted pregnancy treatment was initiated 4 weeks after completing the weight loss phase. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women with a wish to conceive; Women with PCOS (Rotterdam criteria); 28 kg/m2≤BMI<35kg/m2;
Key exclusion criteria (1 listed)
- Women with medical morbidity; Endocrine disorders; Abnormalities in liver and kidney function; Other medications such as glucocorticoids, anti-androgen drugs ;(spironolactone, cyproterone acetate, flutamide, etc.) within the last 3 months; Acute infections, severe cardiovascular disease, malignant tumors; Ongoing weight loss therapy (>5% weight loss in the last 3 months) or history of gastrointestinal surgery; Uterine anomalies or untreated tubal hydrosalpinx; Receiving a donor oocyte or donor sperm cycle; Chromosome abnormality or recurrent miscarriage; planning preimplantation genetic testing (PGT); Any other contraindications to fertility treatment; Allergic to or contraindicated for GLP-1 class medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLP-1 receptor agonistAlso: Benaglutide3 months | Drug | GLP-1 RAs combined with metformin and healthy lifestyle education |
| Metformin3 months | Drug | GLP-1 RAs combined with metformin and healthy lifestyle education, metformin and healthy lifestyle education |
| healthy lifestyle education3 months | Behavioural | GLP-1 RAs combined with metformin and healthy lifestyle education, metformin and healthy lifestyle education |
Primary outcome
Live birth rate
Time frame: 18 months
12 secondary outcomes
BMI change from baseline to the 3rd month in kg/m2
Time frame: 3 months
Spontaneous resumption of ovulation
Time frame: 3 months
Clinical pregnancy
Time frame: 9 months
Ongoing pregnancy
Time frame: 11 months
Pregnancy loss
Time frame: 18 months
Gestational age at delivery
Time frame: 18 months
Time to pregnancy leading to live birth
Time frame: 18 months
Hypertensive disorders of pregnancy
Time frame: 18 months
Gestational diabetes
Time frame: 18 months
Birth weight in kg
Time frame: 18 months
Neonatal mortality
Time frame: 18 months
Major congenital anomaly
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLP-1 receptor agonist, Metformin and healthy lifestyle education in people with Polycystic Ovary Syndrome and Obesity, run by Peking University Third 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 14 Jan 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuo Huang (+861082266699, homelyleaf@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2025.