Polycystic Ovary SyndromePhase 1NCT06222437
Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy
A Phase 1 study testing Semaglutide in people with Polycystic Ovary Syndrome, run by Methodist Health System.
Trial summary
The purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Semaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Feb 2027
- Phase
- Phase 1
- 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
- Age 18-45
- Body mass index(BMI) > 30
- Diagnosis of PCOS
- Normal thyroid stimulating hormone, prolactin, follicle-stimulating hormone (FSH), estradiol, and normal progesterone
Who cannot join
- Medications excluded: any hormone-containing contraceptive - oral contraceptive pills, Progesterone-only pill, depo-provera, oral provera, progesterone-containing intrauterine contraceptive device
- Letrozole, clomiphene citrate, FSH therapy
- Androgen receptor blockers
- 5α reductase inhibitors
- Insulin
- Hysterectomy
- Endometrial ablation
About this study
The purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.
Read the detailed description
The study mainly focused for the following objectives:
To determine the effect of semaglutide on ovulation and menstrual regularity. To determine the effect of semaglutide on androgen levels, namely testosterone, sex hormone binding globulin, and changes in hirsutism.
To determine changes in weight, body mass index (BMI), and Glycated Hemoglobin( HbA1c) with semaglutide therapy.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Semaglutide
- 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.
SemaglutideDrug
effectiveness of semaglutide in PCOS
| Study group | Role | What they receive |
|---|---|---|
| Protocol group | Experimental | PCOS women in the age 18 to 45 years Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of appropriate weekly dose
To access the compliances of the therapy
Measured: 4 weeks
Number of days on therapy
To access the persistence on Semaglutide
Measured: 4 weeks
Secondary outcomes (2)
measure the Weight in kilograms
To access the weight changes during therapy
Measured: 4 weeks
Numbers of days with exercise changes
To access the ability to do exercise during the therapy
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study startFeb 2026 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: IRB did not approve
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222437
- Sponsor's protocol ID
- 046.OBG.2023.D
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy
- ClinicalTrials.gov ID
- NCT06222437
- Acronym / sponsor ID
- 046.OBG.2023.D
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IRB did not approve
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Jan 2024 (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 purpose of this study is to investigate the effect of semaglutide in women with Polycystic Ovarian Syndrome(PCOS ) and determine potential therapeutic benefits.
Detailed description
The study mainly focused for the following objectives:
To determine the effect of semaglutide on ovulation and menstrual regularity. To determine the effect of semaglutide on androgen levels, namely testosterone, sex hormone binding globulin, and changes in hirsutism.
To determine changes in weight, body mass index (BMI), and Glycated Hemoglobin( HbA1c) with semaglutide therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protocol group | Experimental | Drug: SemaglutidePCOS women in the age 18 to 45 years |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-45
- Body mass index(BMI) > 30
- Diagnosis of PCOS
- Normal thyroid stimulating hormone, prolactin, follicle-stimulating hormone (FSH), estradiol, and normal progesterone
Key exclusion criteria (7 listed)
- Medications excluded: any hormone-containing contraceptive - oral contraceptive pills, Progesterone-only pill, depo-provera, oral provera, progesterone-containing intrauterine contraceptive device
- Letrozole, clomiphene citrate, FSH therapy
- Androgen receptor blockers
- 5α reductase inhibitors
- Insulin
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 |
|---|---|---|
| Semaglutideeffectiveness of semaglutide in PCOS | Drug | Protocol group |
Primary outcome
Number of appropriate weekly dose
Time frame: 4 weeks
To access the compliances of the therapy
Number of days on therapy
Time frame: 4 weeks
To access the persistence on Semaglutide
2 secondary outcomes
measure the Weight in kilograms
Time frame: 4 weeks
Numbers of days with exercise changes
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Semaglutide in people with Polycystic Ovary Syndrome, run by Methodist Health System.
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 4 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: withdrawn, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of appropriate weekly dose (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 23 Mar 2026.