Polycystic OvaryPhase 3NCT05965908
Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome
A Phase 3 study testing liraglutide and Metformin in people with Polycystic Ovary, run by Beni-Suef University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary
- What is being tested?
- liraglutide and Metformin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged 18-45 years
- Poly cystic ovary syndrome based on the Rotterdam criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Beni-suef university Hospital
Banī Suwayf, Beni Suweif Governorate, 62521
About this study
Official title: 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.
Read the 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.
- Conditions
- Polycystic Ovary
- Being tested
- liraglutide, Metformin
- Keywords
- polycystic ovary, liraglutide
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Also called saxenda ampoules
glucagon-like peptide 1 receptor agonist
MetforminDrug
Also called Glucophage 1000mg
biguanide antihyperglycemic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: liraglutide |
| metformin | Active comparator | the patient is given Glucophage 1000 mg tab once daily after lunch for 6 months Receives: Drug: Metformin |
| control | No intervention | not given any drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance (HOMA-IR)
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Aug 2024
- Primary completion30 Nov 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic OvaryStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Abdallah Mohamed Salem, Beni-Suef University
- Investigators
- Beni-Suef University, Study director, Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965908
- Sponsor's protocol ID
- Liraglutide Polycystic Ovary
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected data
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Liraglutide on Different Parameters (Clinical , Metabolic and Hormonal) in Obese Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT05965908
- Acronym / sponsor ID
- Liraglutide Polycystic Ovary
- Conditions
- Polycystic Ovary
- Keywords
- polycystic ovary, liraglutide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| liraglutide | Experimental | Drug: liraglutidewill 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: Metforminthe patient is given Glucophage 1000 mg tab once daily after lunch for 6 months |
| control | No intervention | –not given any drug |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women aged 18-45 years
- Poly cystic ovary syndrome based on the Rotterdam criteria
Key exclusion criteria (7 listed)
- congenital adrenal hyperplasia,
- poorly controlled thyroid disease
- Taking antidiabetic drugs which can affect insulin resistance
- chronic kidney disease
- liver dysfunction (AST or ALT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideAlso: saxenda ampoulesglucagon-like peptide 1 receptor agonist | Drug | liraglutide |
| MetforminAlso: Glucophage 1000mgbiguanide antihyperglycemic | Drug | metformin |
Primary outcome
Insulin Resistance (HOMA-IR)
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Yes. all collected data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beni-Suef University study director
Clinical Pharmacy Faculty of Pharmacy Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing liraglutide and Metformin in people with Polycystic Ovary, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance (HOMA-IR) (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.