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NCT Number: NCT07166081

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

This is a Phase 1, single-center, randomized, placebo-controlled, ascending dose study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM0504 following daily oral 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

Location status: Recruiting

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: One or more symptoms of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia
  • Have a stable body weight (<5% self-reported change during the previous 12 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.
  • 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

BGM0504

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Number of treatment adverse events

    Time frame: 11 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: 11 weeks

  2. Change in fasting weight at week 11

    Time frame: 11 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Double-Blind, Randomized, Ascending-Dose, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets Orally Administered in Non-diabetic Overweight or Obese Adult Subjects

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 19, 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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