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

B

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase

Active, not recruiting
Phase 1

Conditions

Non-diabetic Overweight or Obese

Treatments

Drug: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
Drug: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.
Drug: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Study type

Interventional

Funder types

Industry

Identifiers

NCT06714955
BGM0504-P1-001-US

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 3 patient groups, including a placebo group

Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
Experimental group
Description:
Drug: BGM0504 Administered SC
Treatment:
Drug: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
Experimental group
Description:
Drug: BGM0504 Administered SC
Treatment:
Drug: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.
Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.
Placebo Comparator group
Description:
Drug: Placebo Administered SC
Treatment:
Drug: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Trial contacts and locations

1

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Central trial contact

Charmagne G Beckett, MD, MPH, FACP

Data sourced from clinicaltrials.gov

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