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NCT06125587
Chiglitazar/Metformin in Non-obese Women With PCOS
Phase 2, PHASE3 trial testing Chiglitazar in Polycystic Ovary Syndrome in 55 participants. Completed in 20 November 2024.
31 October 2024
Quick facts
| Lead sponsor | Shengjing Hospital |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 55 |
| Start date | 15 November 2023 |
| Primary completion | 31 October 2024 |
| Estimated completion | 20 November 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Chiglitazar — full drug profile →
- Metformin (metformin) — full drug profile →
Conditions studied
- Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →
- Chiglitazar — all drugs for Chiglitazar →
- Metformin — all drugs for Metformin →
Sponsor
Shengjing Hospital
Who can join
Adults 18 to 45, female only, with Polycystic Ovary Syndrome or Chiglitazar. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3 -
The effects of chiglitazar and metformin on insulin resistance in women with a normal BMI and polycystic ovary syndrome: a randomized controlled study.
Yang Y, Han Y, Xu J, Gao Y, et al · · 2025 · cited 1× · PMID 41331576 · DOI 10.1186/s12902-025-02082-0
Verify or expand the search:
- PubMed search for NCT06125587
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Chiglitazar
Trials testing the same drug.
- NCT07303803 — A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus · Phase 2 · not yet recruiting
- NCT05681273 — Drug-Drug Interaction Study of Chiglitazar in Healthy Subjects. · Phase 1 · completed
- NCT05515445 — Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function · Phase 1 · completed
- NCT05515458 — Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function · Phase 1 · completed
Other recruiting trials for Polycystic Ovary Syndrome
Currently open trials in the same condition.
- NCT07591246 — Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction · NA · recruiting
- NCT07446985 — Is There a Benefit From Addition of Physical Exercise to Diet Restriction/Limitation in PCOS Women With Asthma? · NA · recruiting
- NCT07385716 — Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome · NA · recruiting
- NCT07366944 — PCOS and Problem of Eye Dryness: Is There a Benefit From Lifetyle Changes · NA · recruiting
- NCT07289399 — Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS? · NA · recruiting
Other Shengjing Hospital trials
Trials by the same sponsor.
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- NCT07497191 — AMH Dynamic Changes to Predict Ovarian Reserve in Perimenopausal Breast Cancer · not yet recruiting
- NCT07320599 — Neuroendoscopic Surgery With Ommaya Reservoir Implantation vs. Burr Hole Drainage for Infantile Postmeningitis Subdural · not yet recruiting
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- NCT07101614 — A Randomized Study of JS004 and Toripalimab Combined With Chemotherapy vs Toripalimab Combined With Chemotherapy vs Chem · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06125587 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shengjing Hospital
- Last refreshed: 1 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06125587.
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