Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

NCT05965908 — Phase 3, Completed, 183 participants, Beni-Suef University

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Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome

Registry	NCT05965908
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	183 (Actual)
Sponsor	Beni-Suef University (Other)
Conditions	Polycystic Ovary
Interventions	liraglutide, Metformin (Drug)
Dates	start 2024-08-01, primary completion 2025-11-30, completion 2025-12-30, first posted 2023-07-28, last updated 2026-08-25
Locations	1 site in Egypt

-Summary

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

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+Detailed description

This prospective randomized clinical trial will be conducted at Gynecology and obstetrics department in Beni Suef University Hospital, Beni suef, Egypt.

The trial will be included 150 women with Poly cystic ovary syndrome based on the Rotterdam criteria.

+Arms and interventions

Arm	Type	Interventions	Description
liraglutide	Experimental	Drug: liraglutide	will receive the drug via daily subcutaneous injection to ensure optimal tolerability, the dose was titrated upward weekly by increments of 0.6 mg (i.e., 1.2 mg/day in week 2, 1.8 mg/day in week 3, 2.4 mg/day in week 4) until reaching the target therapeutic dose of 3.0 mg/day for 6-month study duration.
metformin	Active comparator	Drug: Metformin	the patient is given Glucophage 1000 mg tab once daily after lunch for 6 months
control	No intervention		not given any drug

liraglutide (Drug), also known as saxenda ampoules: glucagon-like peptide 1 receptor agonist
Metformin (Drug), also known as Glucophage 1000mg: biguanide antihyperglycemic

+Outcome measures

Primary outcomes

Insulin Resistance (HOMA-IR) [6-months]

+Eligibility

Sex: Female, ages: 18 Years to 45 Years

Inclusion Criteria:

* women aged 18-45 years
* Poly cystic ovary syndrome based on the Rotterdam criteria

Exclusion Criteria:

1. congenital adrenal hyperplasia,
2. poorly controlled thyroid disease
3. Taking antidiabetic drugs which can affect insulin resistance
4. chronic kidney disease
5. liver dysfunction (AST or ALT
6. Documented use of oral hormonal contraceptives and hormone-releasing implants
7. intolerance or allergy to liraglutide or metformin

+Locations (1)

Facility	City	Country	Status
Beni-suef university Hospital	Banī Suwayf, Beni Suweif Governorate	Egypt

+Investigators

Beni-Suef University, Study director, Clinical Pharmacy Faculty of Pharmacy Beni-Suef University