Bioequivalence Study of BGM0504 Injection

Recruiting Phase 1 Interventional Study
Overweight/Obesity
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
144 (estimated)
Sponsor
BrightGene Bio-Medical Technology Co., Ltd. · Industry
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About This Trial

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).

Trial Locations
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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 o…
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