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Recruiting NCT07382908

Bioequivalence Study of BGM0504 Injection

Phase I Interventional Overweight/Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BGM0504 Injection multi-dose pen, BGM0504 Injection single-dose pen, BGM0504 Injection single-dose pen.
Who it may be relevant to
Registry conditions: Overweight/Obesity. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

  • Drug BGM0504 Injection multi-dose pen
    5 mg, single subcutaneous injection in the abdominal region
  • Drug BGM0504 Injection single-dose pen
    5 mg, single subcutaneous injection in the abdominal region
  • Drug BGM0504 Injection single-dose pen
    5 mg, single subcutaneous injection in the abdominal region

Primary outcome measures

  • Peak Plasma Concentration (Cmax) [Time frame: 0 to 672 hours]
  • Area under the plasma concentration versus time curve (AUC)0-t [Time frame: 0 to 672 hours]
Secondary outcome measures (1)
  • Monitor all the adverse event [Time frame: 29 days]

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..

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Hangzhou First People's Hospital — Hangzhou

Identifiers

NCT: NCT07382908 · BGM0504-BE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗