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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Placebo; Drug: PB-119

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PB-119; PB-119 administered on the first day of week 1-20 according to the dose-escalation design	Drug: PB-119; Administered subcutaneously once a week
Placebo Comparator: Placebo; Matched placebo administered on the first day of week 1-20 according to the dose-escalation design	Drug: Placebo; Administered subcutaneously once a week

What is the study measuring?

Primary Outcome Measures

Outcome 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 (24 week)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PegBio Co., Ltd.
• Investigators: Principal Investigator: Guoping Yang, Ph D, The Third Xiangya Hospital of Central South University; Principal Investigator: Ping Jin, Ph D, The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2024
• Primary Completion (Actual): November 16, 2024
• Study Completion (Actual): December 16, 2024

Study Registration Dates

• First Submitted: March 18, 2024
• First Submitted That Met QC Criteria: March 29, 2024
• First Posted (Actual): April 5, 2024

Study Record Updates

• Last Update Posted (Actual): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: PB119110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No