NCT06125587CompletedPhase 2/3
Chiglitazar/Metformin in Non-obese Women With PCOS
Chiglitazar Versus Metformin for Insulin Resistance in Non-obese Patients With Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 1 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 55 (actual)
- First submitted
- 5 Nov 2023
- Start date
- 15 Nov 2023
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Shengjing Hospital
- Diseases
- Obesity
- NCT number
- NCT06125587
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 55
- From 15 Nov 2023 to the primary completion date, 31 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Drugs that can affect endocrine such as contraceptives and steroids taken in the past 3 months
- 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
- Those who do not follow the doctor's instructions during the medication, or discontinue the treatment due to serious adverse reactions
Other illness
- Confirmed diagnosis of diabetes
- 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
Other
- T level is within the normal range
- Organ dysfunction
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
Related publications
- 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 · PMID 41331576
This page is information, not medical advice. Discuss any trial with your doctor.