Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing Tongren Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue that created on the basis of the Exenatide and modified by polyethylene glycol (PEG).
This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEX168 50 microgram | Experimental | PEX168 50 microgram qw sc. and the medication continued for 8 weeks |
|
| PEX168 100 microgram | Experimental | PEX168 100 microgram qw sc. and the medication continued for 8 weeks |
|
| PEX168 200 microgram | Experimental | PEX168 200 microgram qw sc. and the medication continued for 8 weeks |
|
| PEX168 300 microgram | Experimental | PEX168 300 microgram qw sc. and the medication continued for 8 weeks |
|
| Placebo | Placebo Comparator | Placebo qw sc. and the medication continued for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEX168 | Drug | A injection administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine serum concentrations of PEX168 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determin HbA1c levels of PEX168 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jinkui Yang, Ph.D, M.D | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing tongren hospital | Beijing | Beijing Municipality | China |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000601947 | polyethylene glycol loxenatide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|