Chiglitazar/Metformin in Non-obese Women With PCOS

Polycystic Ovary Syndrome Clinical Trial

Official title:

Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06125587
• Other study ID #: 2023PS581K
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• Start date: November 2023
• Est. completion date: May 2026

Study information

• Verified date: November 2023
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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, we applied chiglitazar and metformin to two groups of PCOS patients to understand their effects on insulin resistance.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: May 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Female aged 18- 45 years old

2. Normal weight BMI 18.5--24

3. Diagnosis of hyperandrogenism T>0.481ng/ml

4. The diagnosis of PCOS is based on the diagnostic criteria established by the Rotterdam consensus

5. No use of drugs affecting reproductive endocrine in the 3 months prior to the clinic visit

Exclusion Criteria:

1. T level is within the normal range

2. Organ dysfunction

3. Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months

4. Confirmed diagnosis of diabetes

5. 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

6. Have other endocrine disorders, such as thyroid dysfunction, adrenal gland disease, hyperprolactinemia, etc.

7. Combined psychiatric disorders and severe primary diseases

8. Allergy to the drug or components of this study

9. Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions

Related Conditions & MeSH terms

• Metformin
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Chiglitazar
Chiglitazar is a novel PPAR agonist. Treatment of type 2 diabetes mellitus by moderate activation of PPARa, PPAR? and PPARd, improving insulin sensitivity, regulating blood glucose, and promoting fatty acid oxidation and utilization.
• Metformin
Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome.

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma insulin level	Changes in insulin level before and after treatment	Three months
Secondary	Total testosterone	Changes in total testosterone (TT)	Three months
Secondary	Sex hormone-binding globulin	Changes in sex hormone-binding globulin (SHBG)	Three months
Secondary	Ratio of luteinizing hormone to follicular estrogen	Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH)	Three months