← Trials/Trial dossier/NCT02467790

UnknownPhase 1

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)

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

NCT IDNCT02467790
Org study IDPEX168-Ih

Timeline

Milestones

Study first posted2015-06-10estimated
Last update posted2016-01-26estimated
Study start2015-02 (month precision)
Primary completion2016-03estimated (month precision)
Study completion2016-05estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age31 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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 endpoints
Primary/protocol endpoint

Pharmacokinetic index

Time frame:Baseline to Day31

descriptive

Secondary/protocol endpoint

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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.