Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects

Phase 1

Active, not recruiting

• Conditions: Non-diabetic Overweight or Obese

• Registration Number: NCT06714955
• Lead Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Brief Summary

This is a Phase 1, double-blind, parallel-arm ,placebo-controlled study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), safety and tolerability of BGM0504 following multiple subcutaneous (SC) administrations in non-diabetic overweight or obese adult subjects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-10-21
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-11-27
• Study First Posted: 2024-12-04
• Primary Completion: 2025-01-21
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-10
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Body mass index (BMI) meeting one of the following requirements:

  1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
  2. Between ≥ 27.0 kg/m2 and < 30.0 kg/m2 (overweight) with at least 1 of the following: 1) One or more of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia; 2) Weight-bearing joint pain; 3) Obesity causing dyspnea or obstructive sleep apnea syndrome

• Have a stable body weight (<5% self-reported change during the previous 8 weeks) before screening

• Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.

Exclusion Criteria

• Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists, or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
• Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.
• Have received drugs that have an impact on body weight within 12 weeks before screening.
• Surgical treatment for obesity.
• Known type I/II diabetes.
• History of acute or chronic pancreatitis or pancreatic injury.
• History of drug abuse or alcoholism at screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of treatment adverse events	10 weeks	The relationship of each adverse event tothe investigational product was assessed by the investigator

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic endpoint: Concentration of BGM0504 in plasma	10 weeks
Change in fasting weight at week 10	10 weeks

Trial Locations

Locations (1)

Pharmaron CPC, Inc; 🇺🇸 Baltimore, Maryland, United States