Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.
Lead Sponsor:
PegBio Co., Ltd.
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy an...
Detailed Description
The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity o...
Eligibility Criteria
Inclusion
- 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) ≥28.0 kg/m2 at screening.
- Weight change \<5% in the past 3 months before screening.
Exclusion
- 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.
- History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
- Abnormal Thyroid-Stimulating Hormone(TSH), free triiodothyronine(FT3), Free thyroxine(FT4) or diagnosed thyroid dysfunction
- History of multiple endocrine neoplasia syndrome type 2 (MEN-2) or medullary thyroid carcinoma (MTC).
- Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
- Systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at screening or randomization.
- PR intervals \> 210 msec and/or QRS wave group time limit \> 120 msec and/or Corrected QT interval using Fridericia's formula（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.
- Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening
- History of bariatric surgery for weight loss 1 year before screening.
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06147544
Start Date
July 6 2023
End Date
April 16 2024
Last Update
April 19 2024
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191