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NCT05760677
Study on the Efficacy and Safety of Chiglitazar Sodium in PCOS With T2DM
Phase 1 trial testing pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone in PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries in 142 participants. Status unknown.
30 September 2023
Quick facts
| Lead sponsor | Affiliated Hospital of Nantong University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 142 |
| Start date | 1 October 2022 |
| Primary completion | 30 September 2023 |
| Estimated completion | 30 September 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- pioglitazone group: lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone — full drug profile →
- the Chiglitazar group: lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar — full drug profile →
Conditions studied
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries — all drugs for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries →
- T2D — all drugs for T2D →
Sponsor
Affiliated Hospital of Nantong University
Who can join
Under 40, female only, with PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries or T2D. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Purpose and significance: To explore the clinical efficacy and safety of Chiglitazar sodium in polycystic ovary syndrome with type 2 diabetes Methods: From October 2022 to September 2024, a total of 142 PCOS with T2DM patients admitted to Department of Endocrinology and Metabolism at the Affiliated Hospital of Nantong University were recruited. Participants are randomized in a ratio of 1:1 into two treatment groups of 71 participants: ① control group；②experimental group. After randomization, the control group was treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ pioglitazone, and the patients in the experimental group were treated with lifestyle intervention+ metformin+ orlistat (obese patients)+ Chiglitazar (32mg QD) until the end of follow-up. The treatment and follow-up period totaled 3 months. Observe the body weight, menstrual cycle and blood glucose control and other related indicators. Type of study: randomized controlled, prospective, intervention study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05760677
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Affiliated Hospital of Nantong University trials
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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 NCT05760677 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Affiliated Hospital of Nantong University
- Last refreshed: 1 August 2023
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/NCT05760677.
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