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NCT Number: NCT06125587

Chiglitazar/Metformin in Non-obese Women With PCOS

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Chiglitazar Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Metformin Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

metformin

Drug

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

Primary outcomes

  1. Plasma insulin level

    Time frame: Three months

    Changes in insulin level before and after treatment

Secondary outcomes

  1. Total testosterone

    Time frame: Three months

    Changes in total testosterone (TT)

  2. Sex hormone-binding globulin

    Time frame: Three months

    Changes in sex hormone-binding globulin (SHBG)

  3. Ratio of luteinizing hormone to follicular estrogen

    Time frame: Three months

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

  4. BMI and WHtR

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

    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.

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2023
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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