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CompletedPhase 1

A Phase I Study of 8-week Continuous Treatment With Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes

A Double-Blind, Multicenter, Randomized Study Evaluating the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Relationship in T2DMs Treated With 8 Weeks Injection of Polyethylene Glycol Loxenatide

Asset

Loxenatide / PEG-loxenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

50

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 19-35HbA1c 7-10%

Primary endpoint

Serum concentrations of PEX168

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 IDNCT01976858
Org study IDPEX168-I-03

Timeline

Milestones

Study first posted2013-11-06estimated
Last update posted2013-11-06estimated
Study start2011-06 (month precision)
Primary completion2011-09actual (month precision)
Study completion2011-12actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 WHO criteria more than 3 months.

2. HbA1C 7.0-10.0% and fasting plasma glucose 7.0-10.0 mmol/L after treatment of diet, exercise or a single oral hypoglycemic agents (metformin , glimepiride or pioglitazone).

3. unused insulin within 3 months prior to the enrollment.

4. Body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months.

5. Normol liver, kidney, heart function.

6. Willing to use physical means of contraception during the trial stage.

7. voluntarily to participate in the study.

Exclusion criteria

1. 1 diabetes.

2. used GLP-1, GLP-1 analogs or DPP-4 inhibitors in the past 3 months.

3. have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history

4. There is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma.

5. with severe diabetes complications ( renal , retinal , nerve , vascular disease).

6. has acute and chronic pancreatitis history ;

7. heart failure , unstable angina , severe arrhythmia, patients with a history of myocardial infarction ;

8. There is a history of hypertension and blood pressure is not well controlled : SBP> 160mmHg and / or DBP> 95mmHg persons ;

9. severe chronic gastrointestinal disease ( active ulcer nearly six months ) or have been affecting drug absorption in patients treated ;

10. There are obvious blood system diseases ;

11. There are other endocrine system diseases , such as hyperthyroidism , etc. ;

12. with severe trauma or surgery , severe infection ;

13. have mental illness , drug or other substance abuse or alcoholism ( drinking at least 2 times per week , more than 100g each drink ) ;

14. used any drugs that may affect the study , within 3 months before treatment as the subjects participated in any clinical trials ;

15. within the past six months more than 400ml of blood loss (including blood , trauma or other reasons ) ;

16. were receiving steroids or are receiving cancer treatment ;

17. has been prepared during pregnancy or pregnancy test in female patients ;

18. hepatitis B HBeAg , hepatitis C antibody positive , HIV antibody positive , syphilis antibody positive .

19. skin test positive of PEX168;

20. The researchers considered any factors that the subject should not participate in this trial.

Endpoints (3)

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.

Coverage by outcome category

Glycemic / diabetes
1
Safety / tolerability / PK
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

To determin HbA1c levels of PEX168

Time frame:8 weeks

descriptive

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

To assess number of participants with Adverse Events as a Measure of Safety and To assess number of participants with Adverse Events as a Measure of Safety and Tolerability

Time frame:8 weeks

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

To determine serum concentrations of PEX168

Time frame:8 weeks

concentration, descriptive

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.