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Polyethylene Glycol Loxenatide Pharmacokinetics Study in Subjects With Normal and Insufficiency Renal Function
Kinetic Study of Human Pharmacokinetics in Normal Renal Function, and Renal Insufficiency Subject of Polyethylene Glycol Loxenatide (PEX168)(Open, Non-randomized, Parallel-group)
Lead sponsor
Asset
Loxenatide / PEG-loxenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
24
estimated
Study population
Healthy volunteers, Renal impairment
Key I/E criterion
•BMI ≤28
Primary endpoint
•Pharmacokinetic index
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Age 31-65 (both inclusive) years old, male or female;
2. Weight: Male ≥50kg, female ≥45kg, 18≤BMI≤28;
3. The Cockcroft-Gault (CG) formula to estimate creatinine clearance (CLCr), K / DOQI definition of chronic kidney disease (CKD) 2 patients: 60≤CLcr≤89 ml / min; chronic kidney disease (CKD) 3 patients: 30≤CLcr≤59 ml / min for renal insufficiency,Cockcroft-Gault (CG) formula to estimate creatinine clearance (CLCr) ≥90ml / min for normal subjects.
4. In the 48 hours before the start of the test to the end of the trial period, agreed to get rid of tobacco, alcohol, caffeine, fruit juice subject;
5. Understand the study procedures and methods, voluntarily participate in this experiment, and writing and signed informed consent.
Exclusion criteria
1. Known or suspected of GLP-1 class of drug allergy or allergy;
2. Before screening,received GLP-1 receptor agonists, GLP-1 analogs, DPP-IV inhibitors or any other similar structure of the drug treatment;
3. In addition to the induced renal dysfunction disease itself, suffering from any other organ of acute illness and those with any influence of drugs in vivo study of chronic diseases;
4. within 6 months prior to screening,having any surgery, including the impact of gastric emptying of gastrointestinal surgery;
5. Screened within the previous three months to participate in blood donation and blood donation ≥400mL, or who participate in blood donation or blood transfusion within one month;
6. Within 3 months before screening participated in any drug or medical device trials are (including placebo);
7. Drinking, smoking addiction, drug abuse and drug abusers;
8. In addition to judging laboratory abnormalities diagnosis of renal dysfunction caused by disease, there are other clinically significant laboratory abnormalities (Note: Patients with moderate to severe anemia (Hb <60g / L), severe hypertension ( SBP> 160mmHg and / or diastolic blood pressure> 100mmHg) patients, heart rate> 100bmp, ECG QTc> 450ms were required to exclude;
9. ALT> 1.5 times the upper limit of normal and / or aspartate transaminase> 1.5 times the upper limit of normal and / or total bilirubin> 1.5 times the upper limit of normal;
10. Fasting triglycerides> 5.64mmol / L (500mg / dl);
11. Beyond the normal range of serum amylase, and the clinical significance is determined by the investigator;
12. Pancreatitis, pancreatic cancer a history;
13. Blood thyroid stimulating hormone (TSH) beyond the normal range and clinically significant judgment by the investigator;
14. The pregnancy test was positive women of childbearing age, or pregnant women, breastfeeding women, and within six months there have been unwilling or unable to take family planning and effective contraception during the trial of male / female volunteers;
15. The hepatitis B surface antigen, hepatitis C antibody, HIV antibody, syphilis antibody test positive;
16. Researchers believe any situation that might lead to any subject can not be completed or to the subject of this study bring significant risk.
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Safety / tolerability / PK
2 endpointsPharmacokinetic index
Time frame:Baseline to Day31
descriptive
Incidence of adverse events and serious adverse events
Time frame:Baseline to Day31
event count, event
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- British journal of clinical pharmacology2019 Dec (month)PMID31396983doi:10.1111/bcp.14091via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.