Comparing BGM0504 multi-dose and single-dose injection pens with a reference single-dose pen

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

This test tries to see if a multi-dose BGM0504 pen and an experimental single-dose BGM0504 pen deliver the same amount of drug into the body as the reference single-dose pen in adults who are overweight or obese.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (industry)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07382908 on ClinicalTrials.gov

What this trial studies

This Phase 1 bioequivalence trial gives a single subcutaneous injection of BGM0504 from either a multi-dose pen, an experimental single-dose pen, or the reference single-dose pen to adults who are overweight or obese. Investigators will collect blood samples over time to measure drug concentrations and compare pharmacokinetic parameters between formulations. Key eligibility includes age 18–55, BMI meeting overweight or obese criteria, minimum weight thresholds, no diabetes, and no severe allergic history. The trial is sponsored by BrightGene and conducted at Hangzhou First People's Hospital in Hangzhou, Zhejiang.

Who should consider this trial

Good fit: Adults 18–55 who are overweight or obese (BMI ≥24 kg/m²), meet the minimum weight thresholds, have no diabetes or major allergies, and can comply with study procedures and contraception requirements are ideal candidates.

Not a fit: People with type 1 or 2 diabetes, significant abnormal HbA1c, severe allergic conditions, pregnant or planning pregnancy, or those outside the age/BMI limits are unlikely to benefit from participation.

Why it matters

Potential benefit: If the pens are bioequivalent, patients could have more interchangeable BGM0504 delivery options with the same dosing and expected effects.

How similar studies have performed: Testing different pen formats for the same biologic is a standard regulatory approach and has often shown equivalent drug exposure, though this specific BGM0504 formulation has not been previously reported.

Eligibility criteria

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..

Where this trial is running

Hangzhou, Zhejiang

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

Conditions: Overweight/Obesity