Obesity
Conditions
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 and immunogenicity of PB-718 injection in Chinese obese subjects.
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 of PB-718 injection in Chinese obese subjects. The study consists of three dose groups, each of which is planned to include 12 subjects (9 receiving the study drug and 3 receiving placebo), for a total of 36 patients. Subjects will receive 12 weeks（for cohort 1 and 2） or 18 weeks(for cohort 3) of treatment after screening and complete 8 weeks of safety follow-up.
Interventions
DRUGPB-718
Administered subcutaneously once a week
DRUGPlacebo
Administered subcutaneously once a week
Sponsors
PegBio Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
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) ≥28.0 kg/m2 at screening. 3. Weight change \<5% in the past 3 months before screening.
Exclusion criteria
1. 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), free triiodothyronine(FT3), Free thyroxine(FT4) or diagnosed thyroid dysfunction 5. History of multiple endocrine neoplasia syndrome type 2 (MEN-2) or medullary thyroid carcinoma (MTC). 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. 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. 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 1 year 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 (20 weeks for cohort 1 and cohort 2 or 26 weeks for cohort 3) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic profile | From the first dose (Day 1 ) of study drug until week 12 (for cohort 1 and cohort 2) or week 18(for cohort 3) | Cmax |
| Proportion of participants with ≥5% weight loss | week 12 (for cohort 1 and cohort2) or week 18(for cohort 3) | — |
| Change in body weight from baseline | Week12(for cohort 1 and cohort 2) or week 18(for cohort 3) | — |
| Change in Fasting Plasma Glucose(FPG) from baseline | week 12(for cohort 1 and cohort 2) or week 18(for cohort 3) | — |
Countries
China
Outcome results
None listed