PB119

CompletedPhase 3

Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

A Phase III, Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

Lead sponsor

PegBio Co., Ltd.

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

273

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≤40•HbA1c ≤11%

Primary endpoint

•HbA1c, change

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 IDNCT04504370

Org study IDPB119301

Timeline

Milestones

Study start2020-04-27actual

Study first posted2020-08-07actual

Primary completion2022-03-30actual

Study completion2022-11-28actual

Last update posted2023-07-28actual

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, aged 18~75 years old;

•Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999；

•18.5 kg/m2 < BMI < 40.0 kg/m2 at screening;

•7.5% ≤ HbA1c ≤ 11.0% at screening;

•7.0% ≤ HbA1c ≤ 10.5% when the random;

•18.5 kg/m2 < BMI < 40.0 kg/m2 during screening and before randomization

Exclusion criteria

•T1DM;

•Continuous use of insulin for more than 14 days within 1 year before screening or before randomization；

•Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependent insulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist prior to screening or randomized prior treatment；

•Screening for any of the following heart diseases within the first 6 months or before randomization；

•Patients whose hypertension was not effectively controlled during screening or before randomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；

•Serum amylase or lipase >3×ULN or those with previous diagnosis of acute/chronic pancreatitis were screened or randomly screened；

•Screening for severe trauma or infection that may affect glycemic control within the first month or before randomization；

•A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)；

•Known to be allergic or intolerant to the study drug or metformin；

•Female subjects during pregnancy or lactation.

Endpoints (5)

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

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:week 1, week 25

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index

Time frame:week 1, week 25

BMI, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Primary/protocol endpoint

Change in HbA1c

Time frame:week 1, week 25

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c Below 7.0%

Time frame:week 1, week 25

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:week 1, week 25

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Publications (1)

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.

Registry references + supporting bibliography

Efficacy and safety of visepegenatide, a long-acting weekly GLP-1 receptor agonist as monotherapy in type 2 diabetes mellitus: a randomised, double-blind, parallel, placebo-controlled phase 3 trial.
The Lancet regional health. Western Pacific2024 Jun (month)PMID38948164doi:10.1016/j.lanwpc.2024.101101via clinicaltrials gov reference derived + pubmed nct search

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.