Chiglitazar/Metformin in Non-obese Women With PCOS

NCT ID: NCT06125587

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2024-11-20

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

Conditions

Polycystic Ovary Syndrome; Chiglitazar; Metformin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chiglitazar group

Chiglitazar, tablet, 32mg, taken orally once daily for 3 months

Group Type: EXPERIMENTAL

Chiglitazar

Intervention Type: DRUG

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.

Metformin group

Metformin, tablet, 0.5g, taken orally twice daily for 3 months

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome.

Interventions

Chiglitazar

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.

Intervention Type: DRUG

Metformin

Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yining Yang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

2023PS581K

Identifier Type: -

Identifier Source: org_study_id