> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/bioequivalence-study-of-bgm0504-injection-81e89f3e-cbe5-435a-ada9-a7fcf1d460a9 > Record changed: 2026-10-13 # Bioequivalence Study of BGM0504 Injection NCT07382908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) Participants 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) Lead sponsor BrightGene Bio-Medical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) Start date 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Title and summary **Summary** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Short title** Bioequivalence Study of BGM0504 Injection Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Official title** A Single-Center, Single-Dose, Randomized, Open-Label, Single-Period, Parallel Bioequivalence Study of BGM0504 Injection in Overweight/Obese Participants Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Dates **Completion date** 2026-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **First posted** 2026-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Registry last updated** 2026-02-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Primary completion date** 2026-02-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Start date** 2025-12-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Size and sites **Participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Planned participants** 144 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Lead sponsor** BrightGene Bio-Medical Technology Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Identifiers **Registry ID** NCT07382908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **ClinicalTrials.gov ID** NCT07382908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Outcomes ### Primary outcomes 1. Peak Plasma Concentration (Cmax) Timeframe: 0 to 672 hours Peak Plasma Concentration (Cmax) 2. Area under the plasma concentration versus time curve (AUC)0-t Timeframe: 0 to 672 hours Area under the plasma concentration versus time curve (AUC)0-t ### Secondary outcomes 1. Monitor all the adverse event Timeframe: 29 days Monitor all the adverse event was assessed by the investigator. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** No ### 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.. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Sites - Hangzhou First People's HospitalHangzhou, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07382908) ## Related records ### Drugs (1) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) ### Collaborators (1) - BrightGene Pharmaceutical Co., Ltd. ### Lead sponsors (1) - [BrightGene Bio-Medical Technology Co., Ltd.](https://trialight.com/data/company/brightgene-bio-medical-technology-co-ltd-f4e70e57-5f96-4d10-adaf-95111dfe4eca.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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