PCOSPhase 4LITOPNCT06742710
Liraglutide Treatment in Obese Infertile PCOS Women
A Phase 4 study testing Liraglutide and metformin and Metformin in people with PCOS and Obesity, run by Peking University Third Hospital at 3 sites in China.
Trial summary
Liraglutide, a hypoglycemic drug, can reduce weight and improve insulin resistance while stabilizing blood glucose metabolism without increasing the risk of hypoglycemia, and has been approved by the State Food and Drug Administration of China and the US Food and Drug Administration for the treatment of obesity. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- PCOS, Obesity, Infertility
- What is being tested?
- Liraglutide and metformin and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 890 participants
- Where
- 3 sitesChina
- Study dates
- 22 May 2025to 31 Dec 2029
- Phase
- Phase 4
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with polycystic ovary syndrome (PCOS) who meet the Rotterdam diagnostic criteria.
- Aged 20-40 years;
- 25 kg/m2 ≤ BMI ≤ 35 kg/m2;
- Have not used any anti-diabetes or weight-loss medications (metformin excluded) within the past 3 months;
- Have at least 1 transplantable frozen embryo available at the research center;
- Able to follow the study's contraceptive requirements.
Who cannot join
- Diabetic ketoacidosis or other acute complications of diabetes;
- HbA1c ≥ 9.0% before enrollment;
- Using drugs that affect appetite or nutrient absorption within the past 2 months (metformin excluded);
- Uncontrolled hyperthyroidism or hypothyroidism, hypertension, systemic autoimmune diseases, etc. that may affect pregnancy and fetal development;
- 17 hydroxyprogesterone in follicualr phase > 2.0 ng/ml;
- Serious cardiovascular, digestive, liver, or kidney diseases, HBsAg-positive chronic hepatitis B, active pulmonary tuberculosis, or AIDS, etc. that are infectious or hereditary diseases;
Show all 15Show fewer
- Any psychiatric or psychological disorders requiring drug treatment;
- Poor pregnancy and delivery history: recurrent failed implantations ≥3 times, spontaneous abortions ≥2 times; history of stillbirth, dystocia, or birth defects; previous pregnancies with preeclampsia, eclampsia, or HELLP syndrome;
- Uncontrolled metabolic, autoimmune, or hereditary disease in the husband;
- A contraindication or relative contraindication to using GLP-1 receptor agonists (history of medullary thyroid carcinoma or family history of medullary thyroid carcinoma, acute cholecystitis or pancreatitis in the acute phase or history of previous attacks, GLP-1 receptor agonist allergy, etc.);
- Failure to comply with the contraceptive requirements of the study design;
- Failure to take medication regularly and follow up;
- Current smokers, drug addicts, alcoholics, or individuals with substance abuse;
- Participants who have participated in any clinical trial within the past 3 months prior to screening;
- Individuals with other conditions deemed unsuitable for participation in this clinical trial by the investigator;
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Ye Liu, 8601082265025, yeliumed@bjmu.edu.cn
- Not yet recruiting
Beijing Obstetrics and Gynecology Hospital
Beijing
Prof. Yang, 8601052276699, xiaokuiyang2012@163.com
- Not yet recruiting
Haidian District Maternal and Child Health Care Hospital
Beijing
Prof. Liu, 8601062538899
About this study
Liraglutide, a hypoglycemic drug, can reduce weight and improve insulin resistance while stabilizing blood glucose metabolism without increasing the risk of hypoglycemia, and has been approved by the State Food and Drug Administration of China and the US Food and Drug Administration for the treatment of obesity. Polycystic ovary syndrome (PCOS) is the main cause of female anovulatory infertility, and it is also a high-risk group of obesity. Previous studies have suggested that liraglutide improves glucose metabolism, body weight, and inflammation levels in obese women with PCOS, and improves sex hormone profiles and menstrual cycles, possibly contributing to increased fertility.
Therefore, this project intends to test the following hypothesis through a large sample randomized controlled trial in obese and infertile PCOS women who are assisted by in vitro fertilization-frozen embryo transfer (IVF-FET), using liraglutide before transplantation to reduce weight can improve the live birth rate of assisted reproduction.
- Conditions
- PCOS, Obesity, Infertility
- Being tested
- Liraglutide and metformin, Metformin
- Keywords
- polycystic ovary syndrome, liraglutide, infertile, obesity
- Medical subject headings
- Obesity, Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liraglutide and metforminDrug
Liraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy.
MetforminDrug
Metformin 1500 mg/day until pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Liraglutide 3.0 mg or maximum tolerable dose/day and metformin 1500 mg/day Receives: Drug: Liraglutide and metformin |
| Control Group | Active comparator | Metformin 1500 mg/day Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate associated with single cycle frozen embryo transfer
The rate of live birth of intervention and control groups
Measured: At delivery
Secondary outcomes (8)
Clinical pregnancy rate of single cycle frozen embryo transfer
Viable intrauterine pregnancy confirmed by ultrasound
Measured: Thirty days after the embryo transplantation
Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy
Newly diagnosed diabetes or gestational diabetes at 28 weeks of pregnancy confirmed by 75 g oral glucose tolerance test。
Measured: At 28 weeks of pregnancy
Pregnancy outcome and complications
Rate of miscarriage, multiple pregnancies, pregnancy induced hypertension, preeclampsia, HELLP syndrome, prematurity (< 37 weeks), macrosomia (birth weight > 4 kg), induction of labour, prolonged duration of labour, caesarean section, assisted delivery, peripartum increased blood loss (≥ 800 ml).
Measured: From baseline to delivery
Birth weight for gestational age
Birth weight percentile for gestational age for neonatal sex
Measured: At delivery
Apgar scores
Apgar scores (0~10) of the newborns at delivery
Measured: At delivery
Other perinatal outcomes
Rate of major birth defects, stillbirth, neonatal complications, and neonatal admission to a neonatal intensive care unit.
Measured: At delivery
Accumulated live birth rate
Accumulated liver birth rate associated with the pregnancy achieved during the first 6 months of the study
Measured: At delivery
Accumulated clinical pregnancy rate
Accumulated clinical pregnancy rate achieved during the first 6 months of the study
Measured: At month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start22 May 2025
- Primary completion30 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOSStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742710
- Sponsor's protocol ID
- LITOP
- Acronym
- LITOP
- Status last verified
- Dec 2024
- First submitted
- 4 Aug 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data will be available if researchers provide a methodologically sound proposal and contact to the principal investigator. Data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liraglutide Treatment in Obese Infertile PCOS Women
- ClinicalTrials.gov ID
- NCT06742710
- Acronym / sponsor ID
- LITOP / LITOP
- Conditions
- PCOS, Obesity, Infertility
- Keywords
- polycystic ovary syndrome, liraglutide, infertile, obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 890 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Dec 2024 (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.
Liraglutide, a hypoglycemic drug, can reduce weight and improve insulin resistance while stabilizing blood glucose metabolism without increasing the risk of hypoglycemia, and has been approved by the State Food and Drug Administration of China and the US Food and Drug Administration for the treatment of obesity. Polycystic ovary syndrome (PCOS) is the main cause of female anovulatory infertility, and it is also a high-risk group of obesity. Previous studies have suggested that liraglutide improves glucose metabolism, body weight, and inflammation levels in obese women with PCOS, and improves sex hormone profiles and menstrual cycles, possibly contributing to increased fertility.
Therefore, this project intends to test the following hypothesis through a large sample randomized controlled trial in obese and infertile PCOS women who are assisted by in vitro fertilization-frozen embryo transfer (IVF-FET), using liraglutide before transplantation to reduce weight can improve the live birth rate of assisted reproduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Liraglutide and metforminLiraglutide 3.0 mg or maximum tolerable dose/day and metformin 1500 mg/day |
| Control Group | Active comparator | Drug: MetforminMetformin 1500 mg/day |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Women with polycystic ovary syndrome (PCOS) who meet the Rotterdam diagnostic criteria.
- Aged 20-40 years;
- 25 kg/m2 ≤ BMI ≤ 35 kg/m2;
- Have not used any anti-diabetes or weight-loss medications (metformin excluded) within the past 3 months;
- Have at least 1 transplantable frozen embryo available at the research center;
Key exclusion criteria (15 listed)
- Diabetic ketoacidosis or other acute complications of diabetes;
- HbA1c ≥ 9.0% before enrollment;
- Using drugs that affect appetite or nutrient absorption within the past 2 months (metformin excluded);
- Uncontrolled hyperthyroidism or hypothyroidism, hypertension, systemic autoimmune diseases, etc. that may affect pregnancy and fetal development;
- 17 hydroxyprogesterone in follicualr phase > 2.0 ng/ml;
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 |
|---|---|---|
| Liraglutide and metforminLiraglutide 3.0 mg or maximum tolerable dose/day × 12 weeks and metformin 1500 mg/day until pregnancy. | Drug | Intervention Group |
| MetforminMetformin 1500 mg/day until pregnancy | Drug | Control Group |
Primary outcome
Live birth rate associated with single cycle frozen embryo transfer
Time frame: At delivery
The rate of live birth of intervention and control groups
8 secondary outcomes
Clinical pregnancy rate of single cycle frozen embryo transfer
Time frame: Thirty days after the embryo transplantation
Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy
Time frame: At 28 weeks of pregnancy
Pregnancy outcome and complications
Time frame: From baseline to delivery
Birth weight for gestational age
Time frame: At delivery
Apgar scores
Time frame: At delivery
Other perinatal outcomes
Time frame: At delivery
Accumulated live birth rate
Time frame: At delivery
Accumulated clinical pregnancy rate
Time frame: At month 6
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 29 May 2025.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data will be available if researchers provide a methodologically sound proposal and contact to the principal investigator. Data requestors will need to sign a data access agreement.
Related trials for PCOS
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide and metformin and Metformin in people with PCOS and Obesity, run by Peking University Third Hospital at 3 sites 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 6 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Haining Wang, Professor (8601082265025, hainingmail@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate associated with single cycle frozen embryo transfer (time frame: At delivery). 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 29 May 2025.