Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

August 22, 2026 updated by: Sara Abdallah Mohamed Salem, Beni-Suef University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypt, 62521
        • Beni-suef university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
not given any drug
Experimental: 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.
Drug: liraglutide
glucagon-like peptide 1 receptor agonist
Other Names:
  • saxenda ampoules
Active Comparator: metformin
the patient is given Glucophage 1000 mg tab once daily after lunch for 6 months
Drug: Metformin
biguanide antihyperglycemic
Other Names:
  • Glucophage 1000mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insulin Resistance (HOMA-IR)
Time Frame: 6-months
6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Investigators

  • Study Director: Beni-Suef University, Clinical Pharmacy Faculty of Pharmacy Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

November 30, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

July 20, 2023

First Submitted That Met QC Criteria

July 20, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 22, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Liraglutide Polycystic Ovary

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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