Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

NCT05965908 | Completed Phase 3

• 1 other identifier: Liraglutide Polycystic Ovary
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovary

Keywords

polycystic ovary; liraglutide

Outcome Measures

Primary Outcomes (1)

• Insulin Resistance (HOMA-IR)

  6-months

Study Arms (3)

liraglutide

EXPERIMENTAL

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.

Drug: liraglutide

metformin

ACTIVE COMPARATOR

the patient is given Glucophage 1000 mg tab once daily after lunch for 6 months

Drug: Metformin

control

NO INTERVENTION

not given any drug

Interventions

liraglutide DRUG

glucagon-like peptide 1 receptor agonist

Also known as: saxenda ampoules

liraglutide

Metformin DRUG

biguanide antihyperglycemic

Also known as: Glucophage 1000mg

metformin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Liraglutide; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Beni-Suef University

  Clinical Pharmacy Faculty of Pharmacy Beni-Suef University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynaecology Faculty of medicine Beni-Suef University

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: August 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)