Chiglitazar/Metformin in Non-obese Women With PCOS

December 31, 2024 updated by: Yining Yang, Shengjing Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plasma insulin level
Time Frame: Three months
Changes in insulin level before and after treatment
Three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total testosterone
Time Frame: Three months
Changes in total testosterone (TT)
Three months
Sex hormone-binding globulin
Time Frame: Three months
Changes in sex hormone-binding globulin (SHBG)
Three months
Ratio of luteinizing hormone to follicular estrogen
Time Frame: Three months
Changes in ratio of luteinizing hormone to follicular estrogen (LH/FSH)
Three months
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.
At baseline and at 12 weeks after randomization via a standardized protocol.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shengjing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings