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UnknownPhase 3

Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 Patients

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase IIIa Clinical Study Evaluating PEGylated Loxenatide Injection(PEX168)in Monotherapy of Type 2 Diabetes Mellitus

Asset

Loxenatide / PEG-loxenatide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

Enrollment

406

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 20-40HbA1c ≤11%

Primary endpoint

HbA1c

Identifiers

Registered as

NCT IDNCT02477865
Org study IDPEX168-301

Timeline

Milestones

Study start2014-03-23actual
Study first posted2015-06-23estimated
Primary completion2016-05-15actual
Last update posted2017-01-24estimated
Study completion2017-02estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age78 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

(all of the 8 must be met):

1. Type 2 diabetes mellitus confirmed by the 1999 WHO criteria;

2. Men or women;

3. Age at signing the ICF≥18 years and ≤78 years;

4. Body mass index (BMI) 20-40 Kg/m2;

5. At least 8 weeks of treatment with diet control and exercise received prior to screening;

6. No glucose-lowering agents received within the 8 weeks prior to screening;

7. 7.5%≤HbA1c≤11.0% at screening(local or centralized test); 7.0%≤HbA1c≤10.5% at randomization(centralized test),and FBG< 13.9 mmol/L(local test);

8. Ability to understand the procedures and approach of this study, willingness to complete the study in strict compliance with the protocol and to voluntarily sign the ICF.

Exclusion criteria

1. Investigator suspecting the subject of allergy to the study drug;

2. Use of any of the following medications or therapies prior to screening:

1. GLP-1 receptor agonists, GLP-1 analogues, DPP-4 inhibitors or any other incretin analogues.

2. Growth hormone therapy within the 6 months prior to screening;

3. History of drug abuse or alcohol abuse;

4. Participation in any clinical trial within the 3 months prior to screening;

5. Prolonged intravenous, oral or intraarticular treatment with corticosteroids within the 2 months prior to screening;

6. Use of any weight control agents or surgeries within the 2 months prior to screening;

7. Any medications used prior to screening that at the investigator's discretion may confound the interpretation of the efficacy or safety data;

3. History or evidence of any of the following conditions prior to screening:

1. Type 1 diabetes mellitus, single gene mutation DM, DM associated with pancreatic injury,or secondary DM;

2. History of hypertension with SBP>160 mmHg and/or DBP>100 mmHg;

3. History of acute/chronic pancreatitis, history of symptomatic cholecystopathy;

4. History of myeloid C-cell carcinoma, history of multiple endocrine neoplasm (MEN) 2A or 2B syndrome, or related familiar history;

5. Gastric emptying disorders, severe chronic gastrointestinal disorders;

6. History of severe hypoglycemia, unconsciousness or severe hypoglycemia history;

7. Significant hematological disorders, or any diseases;

8. Severe diabetic complications that in the opinion of the investigator make the subject not suitable to participate in this study;

9. Tumors of any organ or system that not been treated within the 5 years prior to screening;

10. Coronary angioplasty, coronary stenting, coronary artery bypass, uncompensated heart failure (NYHA Class III or IV), within the 6 months prior to screening;

11. Acute metabolic complications within the 6 months prior to screening;

12. Thyroid dysfunction within the 6 months prior to screening;

13. Blood lipid disorders within the 6 months prior to screening;

14. Any severe trauma or severe infection within the 1 month prior to screening;

4. Laboratory indicators meeting any of the following criteria prior to screening:

1. ALT>2.5×ULN and/or AST>2.5×ULN and/or total bilirubin>2.5×ULN;

2. Hemoglobin≤100 g/L;

3. Serum creatinine>1.5×UNL and eGFR < 45 ml/min/1.73 m2; eGFR is calculated as:186.3 ×[(Serum Creatinine(mmol/L)/88.4)]-1.154 × [Age (years)]- 0.203 × 1.223 × 0.742 (Females) or ×1(Males)

4. Serum thyroid-stimulating hormone(TSH) out of the reference range that is assessed as clinically significant by the investigator;

5. Fasting TGL>5.64 mmol/L(500 mg/dl);

6. Blood amylase and urine amylase>ULN that is assessed as clinically significant by the investigator;

7. Any clinically significant laboratory abnormalities;

5. Clinically significant 12-lead ECG abnormalities;

6. Blood donation or loss≥400 mL,or receipt of blood donation within the 4 weeks prior to screening;

7. Pregnant or lactating women, or men or women of child-bearing potential not willing to take contraceptive measures during the study;

8. Any other conditions of the subject that at the investigator's discretion may compound the interpretation of the efficacy or safety data.

Endpoints (10)

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
6
Cardiometabolic biomarkers
2
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight measured by standardized procedure.

Time frame:Baseling to 52 weeks

descriptive

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

HbA1c

Time frame:Baseling to 24 weeks

descriptive

Secondary/protocol endpoint

The proportion of HbA1c <6.5% and <7% at the end of the analysis.

Time frame:Baseling to 24 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Fasting plasma glucose

Time frame:Baseling to 52 weeks

concentration, descriptive

Secondary/protocol endpoint

6 points glucose of fingertip

Time frame:Baseling to 24 and 52 weeks

descriptive

Secondary/protocol endpoint

Postprandial blood glucose two hours

Time frame:Baseling to 24 weeks

descriptive

Secondary/protocol endpoint

Postprandial blood glucose two hours AUC

Time frame:Baseling to 24 weeks

concentration, descriptive

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Lipid

Time frame:Baseling to 52 weeks

descriptive

Secondary/protocol endpoint

Blood pressure

Time frame:Baseling to 52 weeks

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame:Baseling to 56 weeks

event count, event

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.