A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.

Obesity Clinical Trial

Official title:

A Single Center, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06147544
• Other study ID #: PB718101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 6, 2023
• Est. completion date: April 16, 2024

Study information

• Verified date: April 2024
• Source: PegBio Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 16, 2024
• Est. primary completion date: April 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• PB-718
Administered subcutaneously once a week
• Placebo
Administered subcutaneously once a week

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
PegBio Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic profile	Cmax	From the first dose (Day 1 ) of study drug until week 12 (for cohort 1 and cohort 2) or week 18(for cohort 3)
Secondary	Pharmacokinetic profile	Tmax	From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort 2) or week 18(for cohort 3)
Secondary	Pharmacokinetic profile	Area under the concentration-time curve over dosing interval(AUC0-tau)	From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort 2) or week 18(for cohort 3)
Secondary	Pharmacokinetic profile	Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC0-last)	From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort2) or week 18(for cohort 3)
Secondary	Pharmacokinetic profile	t1/2	From the first dose (Day 1 ) of study drug until week 12(for cohort 1 and cohort 2) or week 18(for cohort3)
Secondary	Proportion of participants with =5% weight loss		week 12 (for cohort 1 and cohort2) or week 18(for cohort 3)
Secondary	Change in body weight from baseline		Week12(for cohort 1 and cohort 2) or week 18(for cohort 3)
Secondary	Change in Fasting Plasma Glucose(FPG) from baseline		week 12(for cohort 1 and cohort 2) or week 18(for cohort 3)