Clinical trial
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
Recruiting now · Phase 1 · 1 countries · Registry ID NCT07224399
Recruiting nowPhase 1Interventional
What this study 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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 55 Years
SexAll
Healthy volunteersAccepted
ConditionHealhty, Overweight or Obesity
Full registry criteria
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.
Treatments and study arms
BGM1812
Drug
Administered SC.
Placebo
Drug
Administered SC.
BGM1812
Drug
Administered SC.
Placebo
Drug
Administered SC.
Primary outcomes
Number of treatment adverse eventsPredose 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
Study locations
1 locations were listed when this page was built. The first 40 are shown.
Pharmaron CPC, Inc🇺🇸 Baltimore, Maryland, United States
MD, MPH, FACPContact