Recruiting
Phase 1

BGM0504

Sponsor:

BrightGene Bio-Medical Technology Co., Ltd.

Code:

NCT07166081

Conditions

Non-diabetic Overweight or Obese

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

BGM0504

BGM0504

BGM0504

Placebo

BGM0504

Study Details

Brief summary:

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.

Conditions

Non-diabetic Overweight or Obese

Study ID

NCT07166081

Start date

Aug 11, 2025

Status verified date

Aug, 2025

Completion date

May 13, 2026

Anticipated

Primary completion date

Jan 12, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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: 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

20 mg BGM0504 administered orally

experimental: Cohort 2

40 mg BGM0504 administered orally

experimental: Cohort 3

60 mg BGM0504 administered orally

placebo comparator: Placebo

Placebo administered orally

experimental: Cohort 4

80mg BGM0504 administered orally

Interventions

BGM0504

Administered orally

BGM0504

Administered orally

BGM0504

Administered orally

Placebo

Administered orally

BGM0504

Administered orally

Primary outcome measure

  • Number of treatment adverse events [ Time Frame: 11 weeks ]

Central Contacts and Locations

Locations

Pharmaron CPC, Inc

Recruiting

Baltimore, Maryland, United States, 21201

More Information

Sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Last update posted

Sep 19, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BrightGene Bio-Medical Technology Co., Ltd. on 2025-09-19.