Healhty, Overweight or Obesity
Conditions
Brief summary
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.
Interventions
DRUGBGM1812
Administered SC.
DRUGPlacebo
Administered SC.
Sponsors
BrightGene Bio-Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study. * Body mass index (BMI) meeting one of the following requirements: 1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese) (for Cohort 3-6); OR 2. Between ≥ 27.0 kg/m2 and \< 30.0 kg/m2 (overweight) with at least 1 of the following: One or more symptoms of prediabetes (impaired fasting plasma glucose and/or abnormal glucose tolerance), grade 1 hypertension, simple fatty liver or dyslipidemia (For Cohort 3- 6); OR 3. Between ≥ 23.0 kg/m2 and \< 27.0 kg/m2 healthy subjects (for Cohort 1 and Cohort 2) * Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening
Exclusion criteria
* Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to amylin agonist-based therapeutic agents or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis). * Known type I/II diabetes. * Has underwent gastric bariatric surgery in the past, or has had liposuction or fat removal within 1 year before screening, or plan to have bariatric surgery, liposuction or abdominal fat removal during the study period or other surgery that would obviously affect the body weight. * History of acute or chronic pancreatitis or pancreatic injury. * Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment adverse events | Predose up to 6 weeks (Part A) & 9 weeks (Part B) | The relationship of each adverse event to the investigational product was assessed by the investigator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of BGM1812 | Predose through week 6 (Part A) & week 9 (Part B) | PK: AUC of BGM1812 |
| PK: Maximum Observed Concentration (Cmax) of BGM1812 | Predose through week 6 (Part A) & week 9 (Part B) | PK: Cmax of BGM1812 |
| Pharmacodynamics (PD): Change from baseline in fasting body weight | Predose through week 6 (Part A) & week 9 (Part B) | Pharmacodynamics (PD): Change from baseline in fasting body weight |
Countries
United States
Outcome results
None listed