Polycystic Ovary SyndromePhase 1/2NCT06519656
Efficacy of Mazdutide for Treating PCOS
A Phase 1/2 study testing Mazdutide in people with Polycystic Ovary Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Mazdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2024to 18 Sep 2026
- Phase
- Phase 1/2
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- BMI≥28kg/M2
- No plan for pregnancy in the coming 8 months after enrollment
- Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :
- Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles per year; > 90 days for any one cycle
- Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter<10mm), confirmed by ultrasound
- Biochemical hyperandrogenism: total testosterone>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)>4
Who cannot join
- Previous history of acute or chronic pancreatitis or pancreatic injury
- Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b
- Severe hypertriglyceridemia (TG>5mmol/L)
- Type 1 or type 2 diabetes mellitus
- Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc
- Pregnancy or breast-feeding
- Patients with other serious diseases affecting heart, liver, kidney, or other major organs
- Patients with any type of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome
The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Mazdutide
- 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.
MazdutideDrug
Also called GLP-1R and GCGR dual agonist
In the initial 4 weeks, the subjects are given Mazdutide 2mg once weekly. If well tolerated, the dosage is increased to 4mg once weekly for another 4 weeks. If still well tolerated, the dosage is further increased to 6mg once weekly and maintained for the ensuing 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mazdutide Treatment Arm | Experimental | Subcutaneous injection of Mazdutide once weekly for 24 weeks. Receives: Drug: Mazdutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free Androgen Index (FAI)
FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100
Measured: 24 weeks
Secondary outcomes (7)
Times of regular menses
Record of vaginal bleeding within 24 weeks after using Mazdutide
Measured: 24 weeks
Number of immature follicles
Total number of follicles measuring 2-9 mm in diameter on ultrasound
Measured: 24 weeks
Bilateral ovary volume
Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound
Measured: 24 weeks
Serum anti-Mullerian hormone (AMH)
Measurement of serum AMH
Measured: 24 weeks
HOMA insulin resistance index (HOMA-IR)
HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5
Measured: 24 weeks
HbA1c
Measurement of HbA1c
Measured: 24 weeks
body mass index (BMI)
BMI = weight / height² (weight in kilograms and height in meters)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start21 Oct 2024
- Primary completion1 Sep 2026
- Study completion18 Sep 2026
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.
- More trials run by Shanghai Zhongshan HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- XI DONG, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519656
- Sponsor's protocol ID
- B2024-190R2
- Status last verified
- Oct 2024
- First submitted
- 14 Jul 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06519656
- Acronym / sponsor ID
- B2024-190R2
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 18 Sep 2026 (actual)
- First posted
- 25 Jul 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 goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mazdutide Treatment Arm | Experimental | Drug: MazdutideSubcutaneous injection of Mazdutide once weekly for 24 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI≥28kg/M2
- No plan for pregnancy in the coming 8 months after enrollment
- Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :
Key exclusion criteria (8 listed)
- Previous history of acute or chronic pancreatitis or pancreatic injury
- Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b
- Severe hypertriglyceridemia (TG>5mmol/L)
- Type 1 or type 2 diabetes mellitus
- Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc
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 |
|---|---|---|
| MazdutideAlso: GLP-1R and GCGR dual agonistIn the initial 4 weeks, the subjects are given Mazdutide 2mg once weekly. If well tolerated, the dosage is increased to 4mg once weekly for another 4 weeks. If still well tolerated, the dosage is further increased to 6mg once weekly and maintained for the ensuing 16 weeks. | Drug | Mazdutide Treatment Arm |
Primary outcome
Free Androgen Index (FAI)
Time frame: 24 weeks
FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100
7 secondary outcomes
Times of regular menses
Time frame: 24 weeks
Number of immature follicles
Time frame: 24 weeks
Bilateral ovary volume
Time frame: 24 weeks
Serum anti-Mullerian hormone (AMH)
Time frame: 24 weeks
HOMA insulin resistance index (HOMA-IR)
Time frame: 24 weeks
HbA1c
Time frame: 24 weeks
body mass index (BMI)
Time frame: 24 weeks
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 21 Sep 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.
XI DONG, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mazdutide in people with Polycystic Ovary Syndrome, run by Shanghai Zhongshan Hospital at 1 site in China.
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 6 inclusion and 8 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 21 Sep 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 China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Free Androgen Index (FAI) (time frame: 24 weeks). 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 21 Sep 2026.