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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06350812
• Other study ID #: PB119110
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: May 27, 2024
• Est. completion date: April 29, 2025

Study information

• Verified date: June 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, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: April 29, 2025
• Est. primary completion date: April 29, 2025
• 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)

=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.

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• PB-119
Administered subcutaneously once a week
• Placebo
Administered subcutaneously once a week

Locations

Country	Name	City	State
China	The Third XIANGYA Hospital of Central South University	Changsha	Hunan

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 (24 week)
Secondary	Pharmacokinetic profile	Cmax	From the first dose (Day 1 ) of study drug until 20 week
Secondary	Pharmacokinetic profile	Tmax	From the first dose (Day 1 ) of study drug until 20 week
Secondary	Pharmacokinetic profile	area under the curve0(AUC0)-tau	From the first dose (Day 1 ) of study drug until 20 week
Secondary	Pharmacokinetic profile	AUC0-last	From the first dose (Day 1 ) of study drug until 20 week
Secondary	Effectiveness index	Change in body weight from baseline	week 20
Secondary	Effectiveness index	Proportion of participants with =5% weight loss	week 20