Polycystic Ovary SyndromePhase 2/3NCT06125587
Chiglitazar/Metformin in Non-obese Women With PCOS
A Phase 2/3 study testing Chiglitazar and Metformin in people with Polycystic Ovary Syndrome and Chiglitazar, run by Shengjing Hospital at 1 site in China.
Trial summary
Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Chiglitazar, Metformin
- What is being tested?
- Chiglitazar and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2023to 20 Nov 2024
- Phase
- Phase 2/3
- 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
- Female aged 18- 45 years old
- Normal weight BMI 18.5--24
- Diagnosis of hyperandrogenism T>0.481ng/ml
- The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus
- No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit
Who cannot join
- T level is within the normal range
- Organ dysfunction
- Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months
- Confirmed diagnosis of diabetes
- Are on a diet, use weight-affecting medications, or have experienced a weight change of >4.5kg within 3 months prior to the start of the study
- Have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc.
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- Combined psychiatric disorders and severe primary diseases
- Allergy to the drug or components of this study
- Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000
About this study
Official title: Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome
Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Moreover it is often accompanied by insulin resistance and obesity. Now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. Chiglitazar is a novel peroxisome proliferation activated receptor (PPAR) agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. However, there is limited evidence for its treatment of insulin resistance in women with PCOS. Therefore, investigators applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.
- Conditions
- Polycystic Ovary Syndrome, Chiglitazar, Metformin
- Being tested
- Chiglitazar, Metformin
- 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.
ChiglitazarDrug
Chiglitazar is a novel PPAR agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization.
MetforminDrug
Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome.
| Study group | Role | What they receive |
|---|---|---|
| Chiglitazar group | Experimental | Chiglitazar, tablet, 32mg, taken orally once daily for 3 months Receives: Drug: Chiglitazar |
| Metformin group | Active comparator | Metformin, tablet, 0.5g, taken orally twice daily for 3 months Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma insulin level
Changes in insulin level before and after treatment
Measured: Three months
Secondary outcomes (4)
Total testosterone
Changes in total testosterone (TT)
Measured: Three months
Sex hormone-binding globulin
Changes in sex hormone-binding globulin (SHBG)
Measured: Three months
Ratio of luteinizing hormone to follicular estrogen
Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH)
Measured: Three months
BMI and WHtR
Anthropometric indices, including height, weight, waist-to-height ratio (WHtR) and BMI, were assessed at baseline and at 12 weeks after randomization via a standardized protocol.
Measured: At baseline and at 12 weeks after randomization via a standardized protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start15 Nov 2023
- Primary completion31 Oct 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Shengjing 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yining Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125587
- Sponsor's protocol ID
- 2023PS581K
- Status last verified
- Dec 2024
- First submitted
- 5 Nov 2023
- Last updated
- 1 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Y, Han Y, Xu J, Gao Y, He B. The effects of chiglitazar and metformin on insulin resistance in women with a normal BMI and polycystic ovary syndrome: a randomized controlled study. BMC Endocr Disord. 2025 Dec 2;25(1):283. doi: 10.1186/s12902-025-02082-0.
PubMed 41331576
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT06125587
- Acronym / sponsor ID
- 2023PS581K
- Conditions
- Polycystic Ovary Syndrome, Chiglitazar, Metformin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 9 Nov 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.
Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorders in women of reproductive age, and its prevalence rate is from 9% (NIH criteria) to 18% (Rotterdamcriteria). It is clinically characterized by hyperandrogenism, persistent anovulation, and polycystic ovarian changes. Moreover it is often accompanied by insulin resistance and obesity. Now, metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. Chiglitazar is a novel peroxisome proliferation activated receptor (PPAR) agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. However, there is limited evidence for its treatment of insulin resistance in women with PCOS. Therefore, investigators applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiglitazar group | Experimental | Drug: ChiglitazarChiglitazar, tablet, 32mg, taken orally once daily for 3 months |
| Metformin group | Active comparator | Drug: MetforminMetformin, tablet, 0.5g, taken orally twice daily for 3 months |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female aged 18- 45 years old
- Normal weight BMI 18.5--24
- Diagnosis of hyperandrogenism T>0.481ng/ml
- The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus
- No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit
Key exclusion criteria (9 listed)
- T level is within the normal range
- Organ dysfunction
- Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months
- Confirmed diagnosis of diabetes
- Are on a diet, use weight-affecting medications, or have experienced a weight change of >4.5kg within 3 months prior to the start of the study
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 |
|---|---|---|
| ChiglitazarChiglitazar is a novel PPAR agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARα, PPARγ and PPARδ, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization. | Drug | Chiglitazar group |
| MetforminMetformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome. | Drug | Metformin group |
Primary outcome
Plasma insulin level
Time frame: Three months
Changes in insulin level before and after treatment
4 secondary outcomes
Total testosterone
Time frame: Three months
Sex hormone-binding globulin
Time frame: Three months
Ratio of luteinizing hormone to follicular estrogen
Time frame: Three months
BMI and WHtR
Time frame: At baseline and at 12 weeks after randomization via a standardized protocol.
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 1 Jan 2025.
- Derived from this study: PubMed 41331576Yang Y, Han Y, Xu J, Gao Y, He B. The effects of chiglitazar and metformin on insulin resistance in women with a normal BMI and polycystic ovary syndrome: a randomized controlled study. BMC Endocr Disord. 2025 Dec 2;25(1):283. doi: 10.1186/s12902-025-02082-0.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Chiglitazar and Metformin in people with Polycystic Ovary Syndrome and Chiglitazar, run by Shengjing 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 5 inclusion and 9 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 1 Jan 2025. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Plasma insulin level (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06125587, which also lists 1 linked publication.
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 1 Jan 2025.