A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects

Korábbi kezelés

• Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
• Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening

Más betegség

• History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
• 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）
• History of bariatric surgery for weight loss before screening.

Laborértékek

• Fasting Plasma Glucose（FPG） ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes
• FPG <3.9 mmol/L at screening and/or a history of hypoglycemia.
• Abnormal Thyroid-Stimulating hormone(TSH), Serum Free Triiodothyronine（FT3）, Serum Free Thyroxine（FT4） or diagnosed thyroid dysfunction
• 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.
• Serum amylase or lipase > 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.
• Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.

Egyéb

• Systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at screening or randomization.

• Chinese male or female subjects aged 18-60 years (both inclusive).
• Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI)
  • ≥30.0 kg/m2 at screening.
• Weight change <5% in the past 3 months before screening.