UnknownPhase 3

Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and Infertility

Effectiveness of the Combination Liraglutide and Metformin on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With Polycystic Ovarian Syndrome, Obesity and Infertility

Lead sponsor

Mỹ Đức Hospital

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

188

Study population

Obesity / overweight, PCOS, Reproductive / infertility

Eligibility highlights

•BMI ≥27•Female

Primary endpoints

•Body weight, absolute change (kg)•Body weight, % change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05952882

Org study ID08/23/DD-BVMD

Timeline

Milestones

Study first posted2023-07-19actual

Last update posted2023-10-23actual

Study start2023-11-01estimated

Primary completion2025-12-31estimated

Study completion2025-12-31estimated

Assets

Investigational agents

Liraglutide

Who this study enrolls

Obesity / overweightPCOSReproductive / infertility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Female gender

•18-65 years of age

•Diagnosis of polycystic ovary syndrome according to the revised Rotterdam criteria (2003)

•BMI ≥ 27 kg/m2

•Infertility

•Agree to participate in the study

Exclusion criteria

•Type 1 or type 2 diabetes.

•History of acute or chronic pancreatitis.

•Family or individual history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2

•Known hypersensitivity or contraindication to the use of GLP-1 receptor agonists.

•Used of hormonal drugs, drugs causing clinically significant weight changes and drugs affecting glucose tolerance for at least 8 weeks.

•Used a anti-androgen drugs for at least 4 weeks.

•History of malignancy requiring chemotherapy.

•History of taking antidiabetic drugs other than gestational diabetes or weight-loss drugs discontinued for at least 4 weeks.

•History of gastrectomy or device-based intervention to manage obesity

•Eating disorders (anorexia or bulimia) or digestive disorders.

•Substance abuse (Tobacco or alcohol)

•History of major depression or other serious mental disorder.

•Inability or refusal to adhere treatment regimens.

Endpoints (60)

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

Weight & body composition

Glycemic / diabetes

Cardiometabolic biomarkers

Other (unclassified)

Weight & body composition

10 endpoints

Primary/protocol endpoint

Absolute Body Weight (BW)

Time frame:12 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Primary/protocol endpoint

Change in Percent Body Weight

Time frame:12 weeks of treatment

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Body Mass Index (BMI)

Time frame:12 weeks of treatment

descriptive, improvement

Secondary/protocol endpoint

Abdominal Adiposity (Waist Circumference [WC])

Time frame:12 weeks of treatment

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Waist-to-Hip Ratio (WHR)

Time frame:12 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Waist-to Height Ratio [WHtR]

Time frame:12 weeks of treatment

ratio, improvement

Secondary/protocol endpoint

Total Fat Mass Evaluated by BIA

Time frame:12 weeks of treatment

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Total Body Fat (%) by BIA (Bioelectrical Impedance Analysis) machine

Time frame:12 weeks of treatment

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Visceral Fat Level (VFL)

Time frame:12 weeks of treatment

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Total lean body mass

Time frame:12 weeks of treatment

Lean mass

change from baseline, improvement

Glycemic / diabetes

7 endpoints

Secondary/protocol endpoint

Glucose OGTT 0 min

Time frame:12 weeks of treatment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Glucose OGTT 120 min

Time frame:12 weeks of treatment

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Insulin OGTT 0 min

Time frame:12 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Insulin OGTT 120 min

Time frame:12 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Fasting Insulin Sensitivity (HOMA-IR)

Time frame:12 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)

Time frame:12 weeks of treatment

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Gestational Diabetes Mellitus Rate

Time frame:24 months after treatment

event count, event

Cardiometabolic biomarkers

6 endpoints

Secondary/protocol endpoint

Total Cholesterol Levels

Time frame:12 weeks of treatment

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

High Density Lipoprotein Cholesterol (HDL-C)

Time frame:12 weeks of treatment

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Triglyceride Levels (TRG)

Time frame:12 weeks of treatment

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Low Density Lipoprotein Cholesterol (LDL-C)

Time frame:12 weeks of treatment

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Systolic Blood Pressure

Time frame:12 weeks of treatment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic Blood Pressure

Time frame:12 weeks of treatment

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Other clinical outcomes

35 endpoints

Secondary/protocol endpoint

Menstrual Cycle Frequency

Time frame:12 weeks of treatment

Menstrual cyclicity

change from baseline, improvement

Secondary/protocol endpoint

Free Androgen Index (FAI)

Time frame:12 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Total Testosterone Concentrations (T)

Time frame:12 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Sex Hormone Binding Globulin (SHBG)

Time frame:12 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Adrenal Dehydroepiandrosterone Sulfate (DHEAS)

Time frame:12 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

17(OH)-progesterone

Time frame:12 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Androstenedione

Time frame:12 weeks of treatment

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Progesterone

Time frame:12 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Luteinizing Hormone (LH)

Time frame:12 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Follicle Stimulating Hormone (FSH)

Time frame:12 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Ovary Volume

Time frame:12 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Spontaneous Pregnancy Rate

Time frame:12 months after treatment

threshold achievement, improvement

Secondary/protocol endpoint

Assisted Reproductive Therapy Pregnancy Rate

Time frame:12 months after treatment

threshold achievement, improvement

Secondary/protocol endpoint

Cumulative Pregnancy Rate

Time frame:12 months after treatment

threshold achievement, improvement

Secondary/protocol endpoint

Total dosage gonadotropin (GNT)

Time frame:12 weeks of treatment

descriptive

Secondary/protocol endpoint

No. of retrieved oocytes/patient

Time frame:12 weeks of treatment

event count, descriptive

Secondary/protocol endpoint

No. of mature (MII) oocytes/patient

Time frame:12 weeks of treatment

descriptive

Secondary/protocol endpoint

Fertilization rate

Time frame:12 weeks of treatment

descriptive, improvement

Secondary/protocol endpoint

Oocyte degeneration rate

Time frame:12 weeks of treatment

descriptive, improvement

Secondary/protocol endpoint

No. of embryos on day 5/patient

Time frame:12 weeks of treatment

descriptive

Secondary/protocol endpoint/low confidence

No. of blastocysts/patient

Time frame:12 weeks of treatment

event count, descriptive

Secondary/protocol endpoint

Blastulation rate

Time frame:12 weeks of treatment

descriptive

Secondary/protocol endpoint

No. of transferred embryos

Time frame:12 weeks of treatment

event count, descriptive

Secondary/protocol endpoint

Pregnancy rate per cycle

Time frame:12 weeks of treatment

event count, event

Secondary/protocol endpoint

Pregnancy rate per Embryo Transfer (ET)

Time frame:12 weeks of treatment

descriptive, improvement

Secondary/protocol endpoint

Implantation rate

Time frame:12 weeks of treatment

descriptive, improvement

Secondary/protocol endpoint

No. of cancelled fresh Embryo Transfer (ET) because of hyperstimulation risk

Time frame:12 weeks of treatment

event count, event

Secondary/protocol endpoint

No. of cryopreserved embryos/patient

Time frame:12 weeks of treatment

event count, improvement

Secondary/protocol endpoint

Ectopic Pregnancy Rate

Time frame:12 weeks of treatment

event count, event

Secondary/protocol endpoint

Stillbirth Rate

Time frame:24 months after treatment

event count, event

Secondary/protocol endpoint

Abortion Rate

Time frame:24 months after treatment

event count, event

Secondary/protocol endpoint

Gestational hypertensive disorder (GHD) Rate

Time frame:24 months after treatment

event count, event

Secondary/protocol endpoint

Live Birth Rate

Time frame:24 months after treatment

threshold achievement, improvement

Secondary/protocol endpoint

Gestational age at birth

Time frame:24 months after treatment

descriptive

Secondary/protocol endpoint

Type of Delivery Method

Time frame:24 months after treatment

categorical status, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Immaturity rate

Time frame:12 weeks of treatment

descriptive

Secondary/protocol endpoint/low confidence

Cryopreservation

Time frame:12 weeks of treatment

descriptive

Publications (27)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Obesity and reproduction: a committee opinion.
Fertility and sterility2021 Nov (month)PMID34583840doi:10.1016/j.fertnstert.2021.08.018via CT.gov reference
The potential role of incretin-based therapies for polycystic ovary syndrome: a narrative review of the current evidence.
Therapeutic advances in endocrinology and metabolism2021 (year)PMID33552465doi:10.1177/2042018821989238via CT.gov reference
Obesity, Polycystic Ovary Syndrome, and Infertility: A New Avenue for GLP-1 Receptor Agonists.
The Journal of clinical endocrinology and metabolism2020 Aug 1PMID32442310doi:10.1210/clinem/dgaa285via CT.gov reference
Polycystic ovarian syndrome: Correlation between hyperandrogenism, insulin resistance and obesity.
Clinica chimica acta; international journal of clinical chemistry2020 Mar (month)PMID31733195doi:10.1016/j.cca.2019.11.003via CT.gov reference
GLP-1 receptor agonists versus metformin in PCOS: a systematic review and meta-analysis.
Reproductive biomedicine online2019 Aug (month)PMID31229399doi:10.1016/j.rbmo.2019.04.017via CT.gov reference
Effect of body mass index on pregnancy outcomes in a freeze-all policy: an analysis of 22,043 first autologous frozen-thawed embryo transfer cycles in China.
BMC medicine2019 Jun 26PMID31238940doi:10.1186/s12916-019-1354-1via CT.gov reference
The Discovery and Development of Liraglutide and Semaglutide.
Frontiers in endocrinology2019 (year)PMID31031702doi:10.3389/fendo.2019.00155via CT.gov reference
Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome.
Fertility and sterility2018 Aug (month)PMID30033227doi:10.1016/j.fertnstert.2018.05.004via CT.gov reference
Liraglutide increases IVF pregnancy rates in obese PCOS women with poor response to first-line reproductive treatments: a pilot randomized study.
European journal of endocrinology2018 Jul (month)PMID29703793doi:10.1530/EJE-18-0175via CT.gov reference
Effect of liraglutide on ectopic fat in polycystic ovary syndrome: A randomized clinical trial.
Diabetes, obesity & metabolism2018 Jan (month)PMID28681988doi:10.1111/dom.13053via CT.gov reference
How effective are weight-loss interventions for improving fertility in women and men who are overweight or obese? A systematic review and meta-analysis of the evidence.
Human reproduction update2017 Nov 1PMID28961722doi:10.1093/humupd/dmx027via CT.gov reference
The International Glossary on Infertility and Fertility Care, 2017.
Fertility and sterility2017 Sep (month)PMID28760517doi:10.1016/j.fertnstert.2017.06.005via CT.gov reference
Effects of liraglutide on ovarian dysfunction in polycystic ovary syndrome: a randomized clinical trial.
Reproductive biomedicine online2017 Jul (month)PMID28479118doi:10.1016/j.rbmo.2017.03.023via CT.gov reference
The Pathogenesis of Polycystic Ovary Syndrome (PCOS): The Hypothesis of PCOS as Functional Ovarian Hyperandrogenism Revisited.
Endocrine reviews2016 Oct (month)PMID27459230doi:10.1210/er.2015-1104via CT.gov reference
Randomized Controlled Trial of Preconception Interventions in Infertile Women With Polycystic Ovary Syndrome.
The Journal of clinical endocrinology and metabolism2015 Nov (month)PMID26401593doi:10.1210/jc.2015-2778via CT.gov reference
A retrospective cohort study to evaluate the impact of meaningful weight loss on fertility outcomes in an overweight population with infertility.
Fertility and sterility2014 May (month)PMID24581574doi:10.1016/j.fertnstert.2014.01.036via CT.gov reference
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.
European journal of endocrinology2014 Mar (month)PMID24362411doi:10.1530/EJE-13-0797via CT.gov reference
Diagnosis and treatment of polycystic ovary syndrome: an Endocrine Society clinical practice guideline.
The Journal of clinical endocrinology and metabolism2013 Dec (month)PMID24151290doi:10.1210/jc.2013-2350via CT.gov reference
Overweight, obesity and central obesity in women with polycystic ovary syndrome: a systematic review and meta-analysis.
Human reproduction update2012 Nov-Dec (year)PMID22767467doi:10.1093/humupd/dms030via CT.gov reference
Metformin: an old medication of new fashion: evolving new molecular mechanisms and clinical implications in polycystic ovary syndrome.
European journal of endocrinology2010 Feb (month)PMID19841045doi:10.1530/EJE-09-0733via CT.gov reference
Evidence-based and potential benefits of metformin in the polycystic ovary syndrome: a comprehensive review.
Endocrine reviews2009 Feb (month)PMID19056992doi:10.1210/er.2008-0030via CT.gov reference
Does high body mass index increase the risk of miscarriage after spontaneous and assisted conception? A meta-analysis of the evidence.
Fertility and sterility2008 Sep (month)PMID18068166doi:10.1016/j.fertnstert.2007.07.1290via CT.gov reference
Drug insight: insulin-sensitizing drugs in the treatment of polycystic ovary syndrome--a reappraisal.
Nature clinical practice. Endocrinology & metabolism2008 May (month)PMID18364705doi:10.1038/ncpendmet0787via CT.gov reference
Obesity, weight loss, and the polycystic ovary syndrome: effect of treatment with diet and orlistat for 24 weeks on insulin resistance and androgen levels.
Fertility and sterility2008 Apr (month)PMID17980364doi:10.1016/j.fertnstert.2007.04.043via CT.gov reference
Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome (PCOS).
Human reproduction (Oxford, England)2004 Jan (month)PMID14688154doi:10.1093/humrep/deh098via CT.gov reference
Relative risk of conversion from normoglycaemia to impaired glucose tolerance or non-insulin dependent diabetes mellitus in polycystic ovarian syndrome.
Human reproduction (Oxford, England)2001 Sep (month)PMID11527911doi:10.1093/humrep/16.9.1995via CT.gov reference
Profound peripheral insulin resistance, independent of obesity, in polycystic ovary syndrome.
Diabetes1989 Sep (month)PMID2670645doi:10.2337/diab.38.9.1165via CT.gov reference

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.