DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06742710

LITOP

RecruitingPhase 4

Liraglutide Treatment in Obese Infertile PCOS Women

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

3

Recruiting sites

1

Enrollment

890

estimated

Study population

Obesity / overweight, PCOS, Reproductive / infertility

Key I/E criteria

•BMI ≤35•Female

Primary endpoint

•Live birth rate associated with single cycle frozen embryo transfer

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06742710
Org study IDLITOP

Timeline

Milestones

Study first posted2024-12-19actual
Study start2025-05-22actual
Last update posted2025-05-29actual
Primary completion2029-05-30estimated
Study completion2029-12-31estimated

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Obesity / overweightPCOSReproductive / infertility

Eligibility

Who can enroll

Minimum age20 Years
Maximum age40 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•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.

Exclusion criteria

•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;
•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;

Endpoints (21)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
10
Glycemic / diabetes
4
Patient-reported / QoL
3
Safety / tolerability / PK
2
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Other/protocol endpoint

Weight

Time frame:At baseline, and week 12

descriptive

Glycemic / diabetes

4 endpoints
Secondary/protocol endpoint

Incidence of newly diagnosed diabetes or gestational diabetes during pregnancy

Time frame:At 28 weeks of pregnancy

T2DM prevention

threshold achievement, event

componentsT2DM prevention

Other/protocol endpoint/low confidence

Oral glucose tolerance test

Time frame:At baseline, week 12, 28 weeks of pregnant, six weeks after delivery

descriptive

Other/protocol endpoint

HbA1c

Time frame:At baseline and week12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other/protocol endpoint

Rate of insulin usage during pregancy

Time frame:Throughout pregnancy

descriptive

Patient-reported / QoL

3 endpoints
Other/protocol endpoint

Anxiety

Time frame:Baseline and week 12

change from baseline, improvement

Other/protocol endpoint

Depression

Time frame:Baseline and week 12

change from baseline, improvement

Other/protocol endpoint

Quality of life specifically for PCOS individuals

Time frame:Baseline and week 12

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Other/protocol endpoint

Drug-related adverse reactions

Time frame:During the treatment with liraglutide or metformin

Treatment-emergent AEs (any)

descriptive, event

Other/protocol endpoint

Major congenital malformations

Time frame:Six weeks after live birth

event count, event

Other clinical outcomes

10 endpoints
Primary/protocol endpoint

Live birth rate associated with single cycle frozen embryo transfer

Time frame:At delivery

threshold achievement, improvement

Secondary/protocol endpoint

Clinical pregnancy rate of single cycle frozen embryo transfer

Time frame:Thirty days after the embryo transplantation

threshold achievement, improvement

Secondary/protocol endpoint

Pregnancy outcome and complications

Time frame:From baseline to delivery

composite event, event

componentsmiscarriage, multiple pregnancy, pregnancy induced hypertension, preeclampsia, hellp syndrome, prematurity lt 37 weeks, macrosomia birth weight gt 4kg, induction of labour, prolonged duration of labour, caesarean section, assisted delivery, peripartum increased blood loss ge 800ml

Secondary/protocol endpoint

Birth weight for gestational age

Time frame:At delivery

descriptive

Secondary/protocol endpoint

Apgar scores

Time frame:At delivery

descriptive

Secondary/protocol endpoint

Other perinatal outcomes

Time frame:At delivery

composite event, event

componentsmajor birth defects, stillbirth, neonatal complications, nicu admission

Secondary/protocol endpoint

Accumulated live birth rate

Time frame:At delivery

threshold achievement, event

Secondary/protocol endpoint

Accumulated clinical pregnancy rate

Time frame:At month 6

threshold achievement, improvement

Other/protocol endpoint

Number of menstrual cycles

Time frame:From to 12 weeks

Menstrual cyclicity

event count, improvement

Other/protocol endpoint

Free testosterone index

Time frame:At baseline, week 12

Androgen, change

change from baseline, improvement

Other (unclassified)

1 endpoint
Other/protocol endpoint

Costs

Time frame:At delivery

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.