Bioequivalence Study of BGM0504 Injection

Recruiting now · Phase 1

Conditions studied: Overweight/Obesity

In brief

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).

Key facts

Study ID

NCT07382908

Run by

BrightGene Bio-Medical Technology Co., Ltd.

People needed

144

Starts

2025-12-23

Expected to finish

2026-02-12

Last updated by the study team

2026-02-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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..

Where it is running

• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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