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

NCT06714955 | Completed Phase 1 FDA Drug

• 1 other identifier: BGM0504-P1-001-US
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-diabetic Overweight or Obese

Outcome Measures

Primary Outcomes (1)

• Number of treatment adverse events

  The relationship of each adverse event tothe investigational product was assessed by the investigator

  10 weeks

Secondary Outcomes (2)

• Pharmacokinetic endpoint: Concentration of BGM0504 in plasma

  10 weeks

• Change in fasting weight at week 10

  10 weeks

Study Arms (3)

Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

EXPERIMENTAL

Drug: BGM0504 Administered SC

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

Drug: BGM0504 Administered SC

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

Drug: Placebo Administered SC

Drug: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Interventions

Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. DRUG

Drug: BGM0504 Administered SC

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. DRUG

Drug: BGM0504 Administered SC

Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.

Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week. DRUG

Drug: Placebo Administered SC

Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Pharmaron CPC, Inc

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 4, 2024
• Study Start: October 21, 2024
• Primary Completion: January 21, 2025
• Study Completion: March 3, 2025
• Last Updated: September 22, 2025

Record last verified: 2024-09

Locations

US (1)