Obesity
Conditions
Brief summary
The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.
Detailed description
The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects. The study consists of 1-2 cohort . 32 patients are planned to be included in each cohort (24 patients receive study drug，8 patients receive placebo) Subjects will receive treatment for 20 weeks after screening and complete 4 weeks of safety follow-up.
Interventions
DRUGPB-119
Administered subcutaneously once a week
DRUGPlacebo
Administered subcutaneously once a week
Sponsors
PegBio Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events | From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit (24 week) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile | From the first dose (Day 1 ) of study drug until 20 week | Cmax |
| Effectiveness index | week 20 | Change in body weight from baseline |
Countries
China
Outcome results
None listed