Trial · Interventional
Status unknownPhase 3Registry data1 trial
Liraglutide and Metformin Combination on Weight Loss, Metabolic - Endocrine Parameters and Pregnancy Rate in Women With PCOS, Obesity and Infertility
NCT05952882est. 1 Nov 2023 to est. 31 Dec 2025
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age and one of the leading causes of infertility. PCOS and obesity affect up to 12.5% - 48.3% Asian women, increase incidence of impaired glucose tolerance, type 2 diabetes and aggravate insulin resistance, cause ovulatory dysfunction and menstrual disorders, and negatively impact outcomes of Assited Reproductive Technology (ART), with higher miscarriage rate when receiving ART. Weight loss decrease insulin resistance and hyperandrogenism, improve ovulation rate and menstrual cycle, significantly higher conception and live birth rates. Weight loss prior to IVF procedures has been associated with significantly improved pregnancy rates (PR) and live birth rates. Furthermore, a decreased number of IVF cycles required to achieve a pregnancy has also been reported after weight loss interventions. Based on the principles of fetal programming, improving a lifestyle before conception might lead to improved longterm health of the offspring. Studies on the effect of anti-obesity medication combined with lifestyle changes on body weight and composition and metabolic - endocrine parameters and pregnancy rate in obese women diagnosed with PCOS are lacking. There is a growing need to develop pharmacologic interventions to improve metabolic function in women with polycystic ovary syndrome (PCOS).
Experimental
LIME 3mg/1500mg
Metformin XR (extended-release) was initiated with a dose of 750 mg once per day for 2 week and increased to 1500 mg once per day for up to 12 weeks. Start injection liraglutide 0.6 mg subcutaneously (SC) 1week daily (QD), then titrated in increments of 0.6 mg once daily every 1 to 3 weeks to a final dose of 3.0 mg liraglutide SC daily for up to 12 weeks.
Active comparator
MET 1500mg
Metformin XR (extended-release) was initiated with a dose of 750 mg once per day for 2 week and increased to 1500 mg once per day for up to 12 weeks
Outcomes the sponsor listed as primary.
Absolute Body Weight (BW)
Time frame · 12 weeks of treatment
Treatment impact on change in body weight after 12 weeks of treatment.
Change in Percent Body Weight
Time frame · 12 weeks of treatment
Treatment effect on reducing body weight expressed as percent body weight loss from baseline
Body Mass Index (BMI)
Time frame · 12 weeks of treatment
Treatment effect in reducing body mass
Abdominal Adiposity (Waist Circumference [WC])
Time frame · 12 weeks of treatment
Treatment effect on loss of waist circumference (abdominal adiposity) with drug treatment
Waist-to-Hip Ratio (WHR)
Time frame · 12 weeks of treatment
Change in central adiposity with treatment as measured by waist-to-hip ratio. A reduction in ratio indicates a decrease in truncal fat.
Waist-to Height Ratio [WHtR]
Time frame · 12 weeks of treatment
Treatment effect on loss of central adiposity as determined by Waist-to Height Ratio. The lower the ratio indicates less abdominal adiposity.
Total Fat Mass Evaluated by BIA
Time frame · 12 weeks of treatment
Treatment effect on reduction of fat mass (kg)
Total Body Fat (%) by BIA (Bioelectrical Impedance Analysis) machine
Time frame · 12 weeks of treatment
Treatment effect on reduction of percent body fat by BIA
Visceral Fat Level (VFL)
Time frame · 12 weeks of treatment
Treatment effect on reduction of visceral fat level by BIA
Total lean body mass
Time frame · 12 weeks of treatment
Treatment impact on total lean body mass
Glucose OGTT 0 min
Time frame · 12 weeks of treatment
Treatment effect on fasting glucose prior to an oral glucose tolerance test (OGTT)
Glucose OGTT 120 min
Time frame · 12 weeks of treatment
Treatment effect on glucose measured at 120 minutes of an oral glucose tolerance test (OGTT)
Insulin OGTT 0 min
Time frame · 12 weeks of treatment
Treatment effect on fasting insulin prior to an oral glucose tolerance test (OGTT)
Insulin OGTT 120 min
Time frame · 12 weeks of treatment
Treatment effect on insulin measured at 120 minutes of an oral glucose tolerance test (OGTT)
Fasting Insulin Sensitivity (HOMA-IR)
Time frame · 12 weeks of treatment
Treatment effect on the HOMA-IR which is an insulin resistance measured derived from fasting blood glucose and insulin . The higher the number the more insulin resistant.
Matsuda Insulin Sensitivity Index Derived From the OGTT (SI OGTT)
Time frame · 12 weeks of treatment
The SI OGTT is a measure of peripheral insulin sensitivity derived from the insulin and glucoses measured during an OGTT. A increase in SI OGTTindicates greater insulin sensitivity
Total Cholesterol Levels
Time frame · 12 weeks of treatment
Treatment impact on improving total cholesterol levels
High Density Lipoprotein Cholesterol (HDL-C)
Time frame · 12 weeks of treatment
Impact of treatment on HDL levels after 12 weeks of treatment
Triglyceride Levels (TRG)
Time frame · 12 weeks of treatment
Drug effect of TRG levels after treatment
Low Density Lipoprotein Cholesterol (LDL-C)
Time frame · 12 weeks of treatment
Treatment impact on improving LDL-C after treatment
Systolic Blood Pressure
Time frame · 12 weeks of treatment
Treatment impact on systolic blood pressure
Diastolic Blood Pressure
Time frame · 12 weeks of treatment
Treatment impact on reducing diastolic blood pressure
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
4 studies on this page
Indexing hint: Randomized controlled trial · 2018
Frøssing et al. 2018Diabetes, obesity & metabolismcited by 137
PMID 28681988DOI 10.1111/dom.13053PUB-28681988
Indexing hint: Randomized controlled trial · 2018
Salamun et al. 2018European journal of endocrinologycited by 155
PMID 29703793DOI 10.1530/eje-18-0175PUB-29703793
Indexing hint: Randomized controlled trial · 2017
Nylander et al. 2017Reproductive biomedicine onlinecited by 109
PMID 28479118DOI 10.1016/j.rbmo.2017.03.023PUB-28479118
Indexing hint: Randomized controlled trial · 2014
Jensterle Sever et al. 2014European journal of endocrinologycited by 124
PMID 24362411PMC3922503DOI 10.1530/eje-13-0797PUB-24362411
3 studies on this page
Indexing hint: Review · 2021
Abdalla et al. 2021Therapeutic advances in endocrinology and metabolismcited by 45
PMID 33552465PMC7844452DOI 10.1177/2042018821989238PUB-33552465
Indexing hint: Review · 2020
Cena et al. 2020The Journal of clinical endocrinology and metabolismcited by 217
PMID 32442310PMC7457958DOI 10.1210/clinem/dgaa285PUB-32442310
Indexing hint: Review · 2019
Knudsen et al. 2019Frontiers in endocrinologycited by 700
PMID 31031702PMC6474072DOI 10.3389/fendo.2019.00155PUB-31031702
References listed at the registry that are not in PepBank. They link to PubMed.
Who could join, as posted.
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