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

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 1

Conditions: Non-diabetic Overweight or Obese

Treatments: Drug: BGM0504; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07166081

BGM0504 Oral-P1-CPK01-US

Details and patient eligibility

About

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.

Enrollment: 80 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: 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 5 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

20 mg BGM0504 administered orally

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Cohort 2

Experimental group

Description:

40 mg BGM0504 administered orally

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Cohort 3

Experimental group

Description:

60 mg BGM0504 administered orally

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Placebo

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo

Cohort 4

Experimental group

Description:

80mg BGM0504 administered orally

Treatment:

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504

Drug: BGM0504