Chiglitazar/Metformin in Non-obese Women With PCOS

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.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Metformin; Chiglitazar
• Intervention / Treatment: Drug: Chiglitazar; Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Shengjing Hospital Of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma insulin level	Changes in insulin level before and after treatment	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total testosterone	Changes in total testosterone (TT)	Three months
Sex hormone-binding globulin	Changes in sex hormone-binding globulin (SHBG)	Three months
Ratio of luteinizing hormone to follicular estrogen	Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH)	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.	At baseline and at 12 weeks after randomization via a standardized protocol.

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): November 20, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: November 5, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: 2023PS581K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No