Testing BGM1812 injections in healthy, overweight, and obese adults
A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to 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
This trial will see if single and repeated under-the-skin injections of BGM1812 are safe and how the body processes them in healthy, overweight, and obese adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | BrightGene Bio-Medical Technology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07224399 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1, single-center, double-blind, placebo-controlled, dose-escalation trial of subcutaneous BGM1812 in otherwise healthy adults across a range of BMIs. Participants receive single and multiple doses of BGM1812 or placebo while investigators measure pharmacokinetics (how the drug is absorbed and cleared), pharmacodynamics (biologic effects), preliminary efficacy signals, and safety/tolerability. The study enrolls cohorts defined by BMI (healthy, overweight with select metabolic features, and obese) with careful monitoring for adverse events. Results will inform dose selection and safety for future studies.
Who should consider this trial
Good fit: Adults who are otherwise healthy with stable body weight and BMI in the ranges specified for the study (healthy BMI 23.0–<27.0 for early cohorts, overweight 27.0–<30.0 with certain metabolic features, and obese 30.0–40.0 for later cohorts) are ideal candidates.
Not a fit: People with an allergic predisposition (allergic to three or more foods/drugs) or known allergy to amylin-agonist therapies, or those with significant medical conditions outside the study's 'otherwise healthy' criteria, may not benefit or be eligible.
Why it matters
Potential benefit: If successful, BGM1812 could offer a well-tolerated injectable option that favorably affects metabolic markers related to overweight and obesity.
How similar studies have performed: Related amylin-agonist and peptide-based weight-management therapies have shown promising effects on weight and metabolic markers in prior studies, but BGM1812 itself is being tested in humans in this first-in-phase 1 setting.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Pharmaron CPC, Inc — Baltimore, Maryland, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.