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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-diabetic Overweight or Obese
• Intervention / Treatment: Drug: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.; Drug: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.; Drug: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron CPC, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.; Drug: BGM0504 Administered SC	Drug: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.; Drug: BGM0504 Administered SC
Experimental: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.; Drug: BGM0504 Administered SC	Drug: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.; Drug: BGM0504 Administered SC
Placebo Comparator: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.; Drug: Placebo Administered SC	Drug: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.; Drug: Placebo Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment adverse events	The relationship of each adverse event tothe investigational product was assessed by the investigator	10 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic endpoint: Concentration of BGM0504 in plasma	10 weeks
Change in fasting weight at week 10	10 weeks

Collaborators and Investigators

• Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): January 21, 2025
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity
• Other Study ID Numbers: BGM0504-P1-001-US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No