DelfaGLP-1 Atlas

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UnknownPhase 3

Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study Evaluating PEGylated Loxenatide Injection（PEX168）Combined With Metformin in the Treatment of Type 2 Diabetes Mellitus

Asset

Loxenatide / PEG-loxenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

587

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 20-40•HbA1c ≤11%

Primary endpoint

•HbA1c

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 IDNCT02477969
Org study IDPEX168-302

Timeline

Milestones

Study start2014-02-27actual
Study first posted2015-06-23estimated
Primary completion2016-06-22actual
Last update posted2017-01-24estimated
Study completion2017-06estimated (month precision)

Assets

Investigational agents

Loxenatide / PEG-loxenatide

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

：

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 metformin monotherapy received prior to screening

6. No glucose-lowering medications other than metformin 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)

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

(subject to be excluded if meeting any of the followings)

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

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

–GLP-1 receptor agonists, GLP-1 analogues, DPP-4 inhibitors or any other incretin analogues
–Growth hormone therapy within the 6 months prior to screening
–History of drug abuse or alcohol abuse
–Participation in any clinical trial for a pharmaceutical product or medical device within the 3 months prior to screening
–Prolonged (for at least 7 consecutive days) intravenous, oral or intraarticular treatment with corticosteroids within the 2 months prior to screening
–Use of any weight control agents or surgeries that might lead to unstable weight within the 2 months prior to screening, or subjects currently on a weight loss plan not in the maintenance phase
–Any medications used prior to screening that at the investigator's discretion may confound the interpretation of the efficacy or safety data, or use of any medications that may cause common toxicities to major organs, including Chinese herbal medicine

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

–Type 1 diabetes mellitus, single gene mutation DM, DM associated with pancreatic injury， or secondary DM, e.g., DM secondary to Cushing syndrome or acromegalia
–History of hypertension with SBP>160 mmHg and/or DBP>100 mmHg despite glucose-lowering agents at stable dose (for at least 4 weeks)
–History of acute/chronic pancreatitis, history of symptomatic cholecystopathy, and the risk factors for pancreatitis including pancreatic injury
–History of myeloid C-cell carcinoma, history of multiple endocrine neoplasm （MEN） 2A or 2B syndrome, or related familiar history
–Clinically significant gastric emptying disorders, severe chronic gastrointestinal disorders, prolonged treatment with peristalsis stimulants, or gastrointestinal surgery
–History of severe hypoglycemic episode, or severe hypoglycemia without symptoms
–Significant hematological disorders , or any diseases that may lead to hemolysis or unstable RBC
–Severe diabetic complications (e.g., macrovascular and microvascular complications) that in the opinion of the investigator make the subject not suitable to participate in this study
–Tumors of any organ or system that have or have not been treated within the 5 years prior to screening, regardless of whether there is evidence of relapse or metastasis, with the exception of local basal cell carcinoma of the skin
–Coronary angioplasty, coronary stenting, coronary artery bypass, uncompensated heart failure （NYHA Class III or IV）, stroke or transient cerebral ischemic attack, unstable angina, myocardial infarction, and persistent and clinically significant arrhythmia, experienced within the 6 months prior to screening
–Acute metabolic complications (e.g., ketoacidosis, lactic acidosis, hyperosmolar coma) within the 6 months prior to screening
–Thyroid dysfunction treated with unstable therapeutic doses (e.g., thioureas, thyroid hormones) within the 6 months prior to screening
–Blood lipid disorders treated with unstable therapeutic doses (e.g., statins, fibrates) within the 6 months prior to screening
–Any severe trauma or severe infection that may interfere with BG control within the 1 month prior to screening

4. Laboratory indicators meeting any of the following criteria prior to screening (any test meeting the criteria must be repeated within 3 work days for confirmation)

–ALT>2.5×ULN and/or AST>2.5×ULN and/or total bilirubin>2.5×ULN
–Hemoglobin≤100 g/L
–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）
–Serum thyroid-stimulating hormone（TSH） out of the reference range that is assessed as clinically significant by the investigator
–Fasting TGL>5.64 mmol/L（500 mg/dl)
–Blood amylase and urine amylase>ULN that is assessed as clinically significant by the investigator
–Any clinically significant laboratory abnormalities that at the investigator's discretion may confound the interpretation of the efficacy or safety data

5. Clinically significant 12-lead ECG abnormalities, e.g., Grade II or III atrial ventricular block （with the exception of right bundle branch block），long QT syndrome or QTc>500ms

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:Baseline to Week52

descriptive

Glycemic / diabetes

6 endpoints
Primary/protocol endpoint

HbA1c

Time frame:Baseline to Week24

descriptive

Secondary/protocol endpoint

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

Time frame:Baseline to Week24

threshold achievement, improvement

Secondary/protocol endpoint

Fasting plasma glucose

Time frame:Baseline to Week52

concentration, descriptive

Secondary/protocol endpoint

6 points glucose of fingertip

Time frame:Baseline to Week52

descriptive

Secondary/protocol endpoint

Postprandial blood glucose two hours

Time frame:Baseline to Week52

descriptive

Secondary/protocol endpoint

Postprandial blood glucose two hours AUC

Time frame:Baseline to Week52

concentration, descriptive

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Lipid

Time frame:Baseline to Week52

descriptive

Secondary/protocol endpoint

Blood pressure

Time frame:Baseline to Week52

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline to Week 56

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.