Actively Recruiting
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-11-06
60
Participants Needed
1
Research Sites
31 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation study. The study will evaluate the pharmacokinetics (PK), pharmacodynamic (PD), preliminary efficacy, safety and tolerability of BGM1812 following single and multiple SC administrations in normal to overweight or obese but otherwise healthy subjects.
CONDITIONS
Official Title
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign informed consent and follow study requirements
- BMI between 30.0 and 40.0 kg/m2 (obese) for Cohort 3-6
- BMI between 27.0 and less than 30.0 kg/m2 (overweight) with prediabetes symptoms, grade 1 hypertension, simple fatty liver, or dyslipidemia for Cohort 3-6
- BMI between 23.0 and less than 27.0 kg/m2 (healthy) for Cohort 1 and 2
- Stable body weight with less than 5% change in previous 12 weeks before screening
You will not qualify if you...
- Allergic to 3 or more foods or drugs, or allergic to amylin agonist-based drugs, or have severe allergic diseases like asthma, urticaria, or eczematous dermatitis
- Known type I or II diabetes
- Previous bariatric surgery, liposuction, or fat removal within 1 year before screening, or planned during study
- History of acute or chronic pancreatitis or pancreatic injury
- Other conditions deemed unsuitable by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pharmaron CPC, Inc
Baltimore, Maryland, United States, 21201
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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