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
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
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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
Weight & body composition
2 endpointsBody mass index(BMI)
Time frame:2, 4, 8, and 12 weeks
descriptive
Waist and hip circumferences and waist-to-hip ratio
Time frame:12 weeks
ratio, improvement
Glycemic / diabetes
9 endpointsChange of glycosylated hemoglobin(HbA1c)
Time frame:12 weeks
descriptive
Percentage of patients achieving HbA1c <7%
Time frame:12 weeks
threshold achievement, improvement
Percentage of patients achieving HbA1c ≤6.5%
Time frame:12 weeks
threshold achievement, improvement
HbA1c
Time frame:2, 4, and 8 weeks
descriptive
Fasting plasma glucose(FPG)
Time frame:2, 4, 8, and 12 weeks
concentration, descriptive
2-hour postprandial glucose(2-h PPG)
Time frame:4, 8, and 12 weeks
descriptive
Insulin
Time frame:4, 8, and 12 weeks
descriptive
C-peptide
Time frame:4, 8, and 12 weeks
descriptive
Self-monitoring of blood glucose (SMBG)
Time frame:4, 8, and 12 weeks
descriptive
Cardiometabolic biomarkers
2 endpointsBlood pressure(both systolic and diastolic)
Time frame:2, 4, 8, and 12 weeks
descriptive
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.
Registry references + supporting bibliography
- Expert opinion on emerging drugs2019 Jun (month)PMID30957581doi:10.1080/14728214.2019.1604684via clinicaltrials gov reference derived
- PMID33687487via clinicaltrials gov reference derived
Provenance
Sources
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.