NCT07382908CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 144 (actual)
- First submitted
- 26 Jan 2026
- Start date
- 29 Dec 2025
- Primary completion date
- 9 Apr 2026
- Lead sponsor
- BrightGene Bio-Medical Technology Co., Ltd.
- Diseases
- Obesity
- NCT number
- NCT07382908
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 144
- From 29 Dec 2025 to the primary completion date, 9 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in any drug or medical device clinical trial and receiving investigational product/device intervention within 3 months prior to screening.
Other illness
- 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.
- 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.
- Any other condition considered by the investigator as unsuitable for participation or participant withdrawal due to personal reasons..
Lab values
- Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hangzhou First People's Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.