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Trial Title:
Chiglitazar/Metformin in Non-obese Women With PCOS
NCT ID:
NCT06125587
Condition:
Polycystic Ovary Syndrome
Chiglitazar
Metformin
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Metformin
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chiglitazar
Description:
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.
Arm group label:
Chiglitazar group
Intervention type:
Drug
Intervention name:
Metformin
Description:
Metformin is not only an antihyperglycemic drug, it also corrects insulin resistance and
hyperandrogenism in polycystic ovary syndrome.
Arm group label:
Metformin group
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, we applied chiglitazar and metformin to
two groups of PCOS patients to understand their effects on insulin resistance.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Start date:
November 2023
Completion date:
May 2026
Lead sponsor:
Agency:
Shengjing Hospital
Agency class:
Other
Source:
Shengjing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06125587
