TirzepatideNCT07811895
Dual GIP/GLP-1 Receptor Agonist in Obese Women Before Frozen Embryo Transfer
A study testing Dual GIP/GLP-1 receptor agonist in people with Tirzepatide and Frozen Embryo Transfer, run by RenJi Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of Dual GIP/GLP-1 receptor agonist pretreatment on reproductive outcomes in obese women before frozen embryo transfer. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Tirzepatide, Frozen Embryo Transfer, Obesity
- What is being tested?
- Dual GIP/GLP-1 receptor agonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,510 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Dec 2030
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 20-40 years;
- Body Mass Index(BMI) ≥ 28kg/m2;
- Women who intend to undergo frozen-thawed embryo transfer;
- At least one embryo available for transfer;
- Be capable of giving informed consent.
Who cannot join
- Women who have been diagnosed with diseases affecting uterine cavity or endometrial receptivity;
- Presence of endocrine disorders that may significantly affect body weight;
- Use of drugs that may cause significant weight changes within 8 weeks before screening;
- Presence of contraindications to the use of dual GIP/GLP-1 receptor agonist;
- Previous bariatric surgery (e.g., gastric bypass) or planning to undergo such surgery during the study period;
- Serum triglycerides (TG) > 5.64mmol/L;
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- Calcitonin≥50 ng/L;
- Presence of medical contraindications to assisted reproductive technology and/or pregnancy;
- Any other condition considered inappropriate for participation by the investigator.
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
RenJi Hospital
Shanghai, Shanghai Municipality, 200025
Yun Sun, Professor, +86 20284574, sunyun_rj@163.com
Yao Lu, +86 20284574, yaoluinrenji@163.com
About this study
Official title: Dual Glucose-dependent Insulinotropic Peptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Receptor Agonist in Women With Obesity for Frozen Embryo Transfer (FET): Pragmatic, Multicenter, Randomized Controlled Trial
To evaluate the efficacy and safety of Dual GIP/GLP-1 receptor agonist pretreatment on reproductive outcomes in obese women before frozen embryo transfer.
- Conditions
- Tirzepatide, Frozen Embryo Transfer, Obesity
- Being tested
- Dual GIP/GLP-1 receptor agonist
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual GIP/GLP-1 receptor agonistDrug
Also called Tirzepatide
16 weeks treatment
| Study group | Role | What they receive |
|---|---|---|
| Delayed FET | Experimental | Participants will receive 16-week tirzepatide pretreatment prior to FET alongside lifestyle modification guidance, with a target weight loss of 10%-15% of total body weight. Receives: Drug: Dual GIP/GLP-1 receptor agonist |
| Standard FET | No intervention | Participants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good birth outcome rate
good birth outcome is defined as live birth(s) at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly.
Measured: at delivery
Secondary outcomes (10)
Biochemical pregnancy rate
biochemical pregnancy is defined as serum beta-human chorionic gonadotropin (β-hCG) ≥10 mIU/ml.
Measured: 12-17 days after frozen embryo transfer
Clinical pregnancy rate
clinical pregnancy is defined as the ultrasound confirmation of at least one intrauterine gestational sac.
Measured: 28-35 days after frozen embryo transfer
Implantation rate
implantation rate is calculated as the number of gestational sacs by a transvaginal ultrasound scan/number of embryos transferred.
Measured: 28-35 days after frozen embryo transfer
Pregnancy loss rate
pregnancy loss is defined as pregnancies that eventuate in a spontaneous abortion or therapeutic abortion that occurred throughout pregnancy.
Measured: From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months
Live birth rate
live birth is defined as the delivery of any neonate with signs of life at ≥ 28 weeks of gestation.
Measured: at delivery
Gestational weight gain
maternal weight gain during pregnancy.
Measured: at delivery
Incidences of obstetric and neonatal complications
including gestational diabetes mellitus, pre-eclampsia, placenta previa, placental abruption, congenital anomalies, postpartum hemorrhage, preterm birth, neonatal respiratory distress syndrome, neonatal jaundice, neonatal infection, neonatal death, etc.
Measured: From the establishment of clinically recognized pregnancy until six weeks after delivery
Incidence of composite endpoint of obesity-related pregnancy complications
composite incidences of miscarriage, gestational diabetes mellitus, hypertensive disorders of pregnancy, and preterm birth.
Measured: From the establishment of clinically recognized pregnancy until six weeks after delivery
Birth weight
birth weight of the newborn at delivery.
Measured: at delivery
Incidence of congenital anomalies
congenital malformations or birth defects.
Measured: From the establishment of clinically recognized pregnancy until six weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TirzepatideStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 1,510 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University, Shanghai Zhongshan Hospital, Shenyang Maternal and Child Health Hospital, Third Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, The Second Hospital of Hebei Medical University, Jiangsu Provincial People's Hospital, Shanghai First Maternity and Infant Hospital, West China Second University Hospital, Nanjing Maternity and Child Health Care Hospital, Anhui Provincial Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Shenyang Jinghua Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Zhengzhou University, Tongji Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Tianjin Central Hospital of Gynecology Obstetrics, Ningbo Women & Children's Hospital
- Responsible party
- Principal investigator, Yun Sun, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811895
- Sponsor's protocol ID
- LY2026-062-B
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Glucose-dependent Insulinotropic Peptide (GIP) and Glucagon-like Peptide-1 (GLP-1) Receptor Agonist in Women With Obesity for Frozen Embryo Transfer (FET): Pragmatic, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07811895
- Acronym / sponsor ID
- LY2026-062-B
- Conditions
- Tirzepatide, Frozen Embryo Transfer, Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,510 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shandong University, Shanghai Zhongshan Hospital, Shenyang Maternal and Child Health Hospital, Third Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital, The Second Hospital of Hebei Medical University, Jiangsu Provincial People's Hospital, Shanghai First Maternity and Infant Hospital, West China Second University Hospital, Nanjing Maternity and Child Health Care Hospital, Anhui Provincial Hospital, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, Shenyang Jinghua Hospital, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Zhengzhou University, Tongji Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Tianjin Central Hospital of Gynecology Obstetrics, Ningbo Women & Children's Hospital
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 10 Sep 2026 (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.
To evaluate the efficacy and safety of Dual GIP/GLP-1 receptor agonist pretreatment on reproductive outcomes in obese women before frozen embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delayed FET | Experimental | Drug: Dual GIP/GLP-1 receptor agonistParticipants will receive 16-week tirzepatide pretreatment prior to FET alongside lifestyle modification guidance, with a target weight loss of 10%-15% of total body weight. |
| Standard FET | No intervention | –Participants will receive lifestyle modification guidance and proceed to FET with no predefined weight-loss target. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women aged 20-40 years;
- Body Mass Index(BMI) ≥ 28kg/m2;
- Women who intend to undergo frozen-thawed embryo transfer;
- At least one embryo available for transfer;
- Be capable of giving informed consent.
Key exclusion criteria (9 listed)
- Women who have been diagnosed with diseases affecting uterine cavity or endometrial receptivity;
- Presence of endocrine disorders that may significantly affect body weight;
- Use of drugs that may cause significant weight changes within 8 weeks before screening;
- Presence of contraindications to the use of dual GIP/GLP-1 receptor agonist;
- Previous bariatric surgery (e.g., gastric bypass) or planning to undergo such surgery during the study period;
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 |
|---|---|---|
| Dual GIP/GLP-1 receptor agonistAlso: Tirzepatide16 weeks treatment | Drug | Delayed FET |
Primary outcome
Good birth outcome rate
Time frame: at delivery
good birth outcome is defined as live birth(s) at ≥37 weeks, with infant birth weight between 2500 and 4000g and without a major congenital anomaly.
10 secondary outcomes
Biochemical pregnancy rate
Time frame: 12-17 days after frozen embryo transfer
Clinical pregnancy rate
Time frame: 28-35 days after frozen embryo transfer
Implantation rate
Time frame: 28-35 days after frozen embryo transfer
Pregnancy loss rate
Time frame: From the date of confirmation of pregnancy until the date of pregnancy loss, up to 9 months
Live birth rate
Time frame: at delivery
Gestational weight gain
Time frame: at delivery
Incidences of obstetric and neonatal complications
Time frame: From the establishment of clinically recognized pregnancy until six weeks after delivery
Incidence of composite endpoint of obesity-related pregnancy complications
Time frame: From the establishment of clinically recognized pregnancy until six weeks after delivery
Birth weight
Time frame: at delivery
Incidence of congenital anomalies
Time frame: From the establishment of clinically recognized pregnancy until six weeks after delivery
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 10 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified participant data
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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 Dual GIP/GLP-1 receptor agonist in people with Tirzepatide and Frozen Embryo Transfer, run by RenJi 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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 Yun Sun, Professor (+86 20284574, sunyun_rj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good birth outcome rate (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 10 Sep 2026.