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Phase 1 Study of BGM1812 for Healthy, Overweight, or Obese Individuals

This study is testing a new medication called BGM1812, given as an injection under the skin, in healthy men and women who are normal weight, overweight, or obese. Researchers want to understand how BGM1812 moves through the body (pharmacokinetics), what effects it has (pharmacodynamics), and if it is safe and well-tolerated. Some participants will receive BGM1812, while others will receive a placebo (an inactive substance). The main goal is to track any side effects. You might be able to join if you are between 18 and 55 years old and meet specific body mass index (BMI) requirements. The study aims to enroll 60 participants.

Study design
This is a Phase 1, single-center, double-blind, placebo-controlled study with increasing doses, involving approximately 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured from before treatment up to 6 weeks (Part A) or 9 weeks (Part B).

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NCT07224399

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
PHASE1Ages 18–55InterventionalTreatment
BrightGene Bio-Medical Technology Co., Ltd.
~60 participants
Updated 2025-11-06 on ClinicalTrials.gov
What's tested:BGM1812Placebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of treatment adverse events
Measured over Predose up to 6 weeks (Part A) & 9 weeks (Part B)

Conditions

Healhty
Overweight or Obesity

Explore related trials

ObesityOverweight

Where it's being run

1 sites across 1 states
Maryland1

Who to contact

MD, MPH, FACP
[email protected]
410-706-8877
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Have a stable body weight (\<5% self-reported change during the previous 12 weeks) before screening

Exclusion

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.

What this trial measures

  • 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