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NCT02467790
Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)
Phase 1 trial testing PEX168 in Type 2 Diabetes Mellitus in 24 participants. Status unknown.
1 March 2016
Quick facts
| Lead sponsor | Jiangsu Hansoh Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 February 2015 |
| Primary completion | 1 March 2016 |
| Estimated completion | 1 May 2016 |
| Sites | 1 location across China |
Drugs / interventions tested
- PEX168 — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd. — full company profile →
Who can join
Adults 31 to 65, any sex, with Type 2 Diabetes Mellitus. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Pharmacokinetic index
Time frame: Baseline to Day31
Prior to administration (within 60 minutes, recorded as 0h) and after administration 24h (Day 2), 48h (Day 3), 72h (day 4), 96h (day 5), 120h (day 6 ), 144h (day 7), 216h (day 10), 312h (day 14 ), 480h (day 21), 648h (day 28), 720h (day 31) collect blood 3 ml and test serum concentrations of PEX168.
Sponsor's own description
To compare and analysis pharmacokinetics of PEX 168 in patients with renal insufficiency or normal renal function who were administrated subcutaneously single dose PEX168.To evaluate dose adjustment of PEX168 administered in patients with renal insufficiency and provide a scientific basis in patients with renal insufficiency of rational drug use.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Polyethylene glycol loxenatide (PEX168) in subjects with renal impairment: A pharmacokinetic study.
Wang J, Huang J, Li W, Tang S, et al · · 2019 · cited 14× · PMID 31396983 · DOI 10.1111/bcp.14091 -
Research Progress on Peptide Drugs for Type 2 Diabetes and the Possibility of Oral Administration.
Yang X, Lin R, Feng C, Kang Q, et al · · 2024 · cited 2× · PMID 39598478 · DOI 10.3390/pharmaceutics16111353
Verify or expand the search:
- PubMed search for NCT02467790
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PEX168
Trials testing the same drug.
- NCT02461914 — Evaluate the Pharmacokinetics of Warfarin When Coadministered With PEX168 in Healthy Adult Subjects · Phase 1 · completed
- NCT02472236 — Evaluate the Pharmacokinetics of Digoxin When Coadministered With PEX168 in Healthy Adult Subjects · Phase 1 · completed
- NCT02447601 — Evaluate the Pharmacokinetics of Simvastatin When Coadministered With PEX168 in Healthy Adult Subjects · Phase 1 · completed
Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
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- NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting
Other Jiangsu Hansoh Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT07468851 — A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radic · Phase 1, PHASE2 · not yet recruiting
- NCT07483437 — A Study of HS-20136-2 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07535970 — A Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10506 in Healthy Chinese Adult Part · Phase 1 · not yet recruiting
- NCT07503015 — Phase 1 Study of HS-20152 in Healthy Participants · Phase 1 · not yet recruiting
- NCT07414953 — A Phase Ib Study of HS-10504 Combined Therapy in NSCLC · Phase 1 · 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 NCT02467790 (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 Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Last refreshed: 23 January 2016
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/NCT02467790.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing