Bioequivalence Study of BGM0504 Injection

A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants

This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).

Study Overview

• Status: Recruiting
• Conditions: Overweight/Obesity
• Intervention / Treatment: Drug: BGM0504 Injection multi-dose pen; Drug: BGM0504 Injection single-dose pen

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Hangzhou First People's Hospital
      • Contact: Ying Wang; Phone Number: 8618367124548; Email: nancywangying@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 18-55 years (inclusive).
• Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI < 28.0 kg/m²) or obese (BMI ≥ 28.0 kg/m²).
• From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm/egg donation.
• The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.

Exclusion Criteria:

• History of severe allergies or severe specific allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.
• Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.
• Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.
• History of acute/chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.
• Past or screening findings of digestive system diseases that may increase participant risk.
• Positive for HBsAg, HCV antibody, syphilis antibody, or HIV antibody at screening.
• Participation in any drug or medical device clinical trial and receiving investigational product/device intervention within 3 months prior to screening.
• Consumption or plan to consume specific foods (including pitaya, mango, grapefruit, pomelo or their juices, high-purine foods like animal organs, seafood, chocolate) or beverages containing caffeine/alcohol within 48 hours before dosing; or unwilling to stop consuming these during the in-house period.
• Pregnant or breastfeeding women, or positive pregnancy test at screening.
• Any other condition considered by the investigator as unsuitable for participation or participant withdrawal due to personal reasons..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Drug: BGM0504 Injection multi-dose pen; 5 mg, single subcutaneous injection in the abdominal region
Experimental: Group B	Drug: BGM0504 Injection single-dose pen; 5 mg, single subcutaneous injection in the abdominal region
Active Comparator: Group C	Drug: BGM0504 Injection single-dose pen; 5 mg, single subcutaneous injection in the abdominal region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax)	Peak Plasma Concentration (Cmax)	0 to 672 hours
Area under the plasma concentration versus time curve (AUC)0-t	Area under the plasma concentration versus time curve (AUC)0-t	0 to 672 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitor all the adverse event	Monitor all the adverse event was assessed by the investigator.	29 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2025
• Primary Completion (Estimated): February 12, 2026
• Study Completion (Estimated): February 12, 2026

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: January 26, 2026
• First Posted (Actual): February 3, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No