A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects
A Single-center, Randomized, Double-blind, Placebo-controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects
Lead sponsor
Asset
Visepegenatide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
32
Study population
Obesity / overweight
Eligibility highlights
-
Primary endpoint
•Treatment-Emergent Adverse Events
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. Chinese male or female subjects aged 18-60 years (both inclusive).
2. Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI)
≥30.0 kg/m2 at screening.
3. Weight change <5% in the past 3 months before screening.
Exclusion criteria
1. Fasting Plasma Glucose(FPG) ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes
2. FPG <3.9 mmol/L at screening and/or a history of hypoglycemia.
3. History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
4. Abnormal Thyroid-Stimulating hormone(TSH), Serum Free Triiodothyronine(FT3), Serum Free Thyroxine(FT4) or diagnosed thyroid dysfunction
5. History of multiple endocrine neoplasia syndrome type 2 (MEN-2) , medullary thyroid carcinoma (MTC) or Category 4 and above thyroid nodules by Thyroid ultrasound Chinese Ultrasound Thyroid Imaging Reporting and Data System (C-TIRADS)
6. Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
7. Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at screening or randomization.
8. Time history from the starting point of P-wave to the starting point of QRS wave(PR intervals )> 210 msec and/or QRS complex(QRS) > 120 msec and/or Corrected QT Interval(QTcF) > 450 msec at screening or randomization.
9. Serum amylase or lipase > 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.
10. Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.
11. Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening
12. History of bariatric surgery for weight loss before screening.
Endpoints (7)
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
Safety / tolerability / PK
5 endpointsIncidence of Treatment-Emergent Adverse Events
Time frame:From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit (24 week)
event count, event
Pharmacokinetic profile
Time frame:From the first dose (Day 1 ) of study drug until 20 week
descriptive
Pharmacokinetic profile
Time frame:From the first dose (Day 1 ) of study drug until 20 week
descriptive
Pharmacokinetic profile
Time frame:From the first dose (Day 1 ) of study drug until 20 week
descriptive
Pharmacokinetic profile
Time frame:From the first dose (Day 1 ) of study drug until 20 week
descriptive
Other (unclassified)
2 endpointsEffectiveness index
Time frame:week 20
descriptive
Effectiveness index
Time frame:week 20
descriptive
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.