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

NCT05952882 · Unknown status

Last updated 2026-05-28

This clinical trial tests whether the combination of liraglutide and metformin helps reduce body weight in women who have polycystic ovary syndrome (PCOS), obesity, and infertility.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 188 people Planned (estimated).

Who can join Ages 18–65 · female only

Timeline Started 2023-11 · est. completion 2025-12

What this study is testing ClinicalTrials.gov NCT05952882 ↗

Description as written by the study sponsor.

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).

Treatments tested

Liraglutide + Metformin also known as LIME Drug

Metformin XR (extended-release) was initiated at 750 mg once daily and increased to 1500 mg once daily after 2 week. Concomitantly, Liraglutide was initiated at a subcutaneous dose of 0.6 mg once daily for 1 week, then titrated in increments of 0.6 mg once daily every 1 to 3 weeks to a maintenance dose of 3.0 mg once daily for up to 12 weeks
Metformin also known as MET Drug

Metformin XR (extended-release) was initiated at 750 mg once daily and increased to 1500 mg once daily after 2 week

Main thing measured	Absolute Body Weight (BW)
Sponsor	Mỹ Đức Hospital
Conditions studied	Polycystic Ovary Syndrome, Obesity, Infertility, Female
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05952882 ↗