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Delfa

← All trials/NCT03520972

CompletedPhase 2

Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Dose Cohort Study to Evaluate the Efficacy and Safety of Twelve Once-weekly Subcutaneous Doses of PB-119 in Drug-naïve Subjects With Type 2 Diabetes Mellitus

Lead sponsor

PegBio Co., Ltd.

Asset

Visepegenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

251

Study population

Type 2 diabetes

Eligibility highlights

•BMI 18.5-35•HbA1c 7.5-11%

Primary endpoint

•Glycosylated hemoglobin(HbA1c)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03520972
Org study IDPB119201

Timeline

Milestones

Study first posted2018-05-11actual
Study start2018-06-05actual
Primary completion2019-07-29actual
Study completion2019-07-29actual
Last update posted2020-01-22actual

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Males and/or females between the ages of ≥18 and ≤70 years at Screening

2. Patients in whom T2DM has been diagnosed according to 1999 WHOT2DM diagnostic criteria

3. HbA1c ≥7.5% and ≤11% at Screening and at Week -1

4. Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at Screening

Exclusion criteria

1. Female who is pregnant, intends to become pregnant or breast-feeding or is of child-bearing potential and not using adequate contraception methods throughout the trial

2. Treatment with any glucose lowing agent(s) within 3 months prior to screening.An exception is short-term treatment (no longer than 7 days in total) with insulin in connection with inter-current illness

3. Calcitonin ≥50 ng/L at screening

4. Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia, type 2

5. Fasting triglyceride ≥500 mg/dL at Screening, or patients with a history of lipid disorders taking unstable treatment dosage (eg, statins) within 3 months prior to screening

6. Any acute or chronic condition that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this trial

7. Blood amylase or lipase >3x ULN, history of acute or chronic pancreatitis, or history of symptomatic gallbladder disease at Screening

8. Serum creatinine ≥1.5 mg/dL (male patients) or ≥1.4 mg/dL (female patients), or estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m2 at Screening

9. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2x upper limit of normal (ULN) at Screening and pre-randomization

10. Severe cardiovascular diseases occurring within 6 months prior to screening

Endpoints (13)

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
9
Weight & body composition
2
Cardiometabolic biomarkers
2

Weight & body composition

2 endpoints
Other/protocol endpoint

Body mass index(BMI)

Time frame:2, 4, 8, and 12 weeks

descriptive

Other/protocol endpoint

Waist and hip circumferences and waist-to-hip ratio

Time frame:12 weeks

ratio, improvement

Glycemic / diabetes

9 endpoints
Primary/protocol endpoint

Change of glycosylated hemoglobin(HbA1c)

Time frame:12 weeks

descriptive

Secondary/protocol endpoint

Percentage of patients achieving HbA1c <7%

Time frame:12 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of patients achieving HbA1c ≤6.5%

Time frame:12 weeks

threshold achievement, improvement

Secondary/protocol endpoint

HbA1c

Time frame:2, 4, and 8 weeks

descriptive

Secondary/protocol endpoint

Fasting plasma glucose(FPG)

Time frame:2, 4, 8, and 12 weeks

concentration, descriptive

Secondary/protocol endpoint

2-hour postprandial glucose(2-h PPG)

Time frame:4, 8, and 12 weeks

descriptive

Secondary/protocol endpoint

Insulin

Time frame:4, 8, and 12 weeks

descriptive

Secondary/protocol endpoint

C-peptide

Time frame:4, 8, and 12 weeks

descriptive

Secondary/protocol endpoint

Self-monitoring of blood glucose (SMBG)

Time frame:4, 8, and 12 weeks

descriptive

Cardiometabolic biomarkers

2 endpoints
Other/protocol endpoint

Blood pressure(both systolic and diastolic)

Time frame:2, 4, 8, and 12 weeks

descriptive

Other/protocol endpoint

Blood lipid

Time frame:2, 4, 8, and 12 weeks

descriptive

Publications (2)

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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.