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OpenTrials
Completed

NCT Number: NCT06714955

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron CPC, Inc

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) meeting one of the following requirements:
  • Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); OR
  • 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.

Treatment and study plan

Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Drug

Drug: BGM0504 Administered SC

Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.

Drug

Drug: BGM0504 Administered SC

Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Drug

Drug: Placebo Administered SC

Primary outcomes

  1. Number of treatment adverse events

    Time frame: 10 weeks

    The relationship of each adverse event tothe investigational product was assessed by the investigator

Secondary outcomes

  1. Pharmacokinetic endpoint: Concentration of BGM0504 in plasma

    Time frame: 10 weeks

  2. Change in fasting weight at week 10

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Double-Blind, Parallel-arm, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection Administered Subcutaneously in Non-diabetic Overweight or Obese Adult Subjects

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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