Chiglitazar/Metformin in Non-obese Women With PCOS

• Sponsor: Shengjing Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06125587
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Chiglitazar; Metformin	Drug: Chiglitazar; Drug: Metformin	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2026
• Anticipated Study Completion Date: May 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chiglitazar group Chiglitazar, tablet, 32mg, taken orally once daily for 3 months	Drug: 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.
Active Comparator: Metformin group Metformin, tablet, 0.5g, taken orally twice daily for 3 months	Drug: Metformin; Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and hyperandrogenism in polycystic ovary syndrome.

Outcome Measures

Primary Outcome Measures

1. Plasma insulin level [Three months]

   Changes in insulin level before and after treatment

Secondary Outcome Measures

1. Total testosterone [Three months]

   Changes in total testosterone (TT)

2. Sex hormone-binding globulin [Three months]

   Changes in sex hormone-binding globulin (SHBG)

3. Ratio of luteinizing hormone to follicular estrogen [Three months]

   Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shengjing Hospital of China Medical University	Shenyang	Liaoning	China	110000

Sponsors and Collaborators

• Shengjing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yining Yang, physician, Shengjing Hospital
• ClinicalTrials.gov Identifier: NCT06125587
• Other Study ID Numbers: 2023PS581K
• First Posted: Nov 9, 2023
• Last Update Posted: Nov 9, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Metformin

Study Results

No Results Posted as of Nov 9, 2023