Chiglitazar/Metformin in Non-obese Women With PCOS

NCT06125587 | Completed Phase 2

• 1 other identifier: 2023PS581K
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Plasma insulin level

  Changes in insulin level before and after treatment

  Three months

Secondary Outcomes (4)

• Total testosterone

  Three months

• Sex hormone-binding globulin

  Three months

• Ratio of luteinizing hormone to follicular estrogen

  Three months

• BMI and WHtR

  At baseline and at 12 weeks after randomization via a standardized protocol.

Study Arms (2)

Chiglitazar group

EXPERIMENTAL

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

Drug: Chiglitazar

Metformin group

ACTIVE COMPARATOR

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

Drug: Metformin

Interventions

Chiglitazar 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.

Chiglitazar group

Metformin DRUG

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

Metformin group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Location

Related Publications (1)

• 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.

  PMID: 41331576 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

chiglitazar; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 9, 2023
• Study Start: November 15, 2023
• Primary Completion: October 31, 2024
• Study Completion: November 20, 2024
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)