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Study of BGM0504 Tablets for Overweight or Obese Adults

This study is testing an investigational drug called BGM0504 in tablet form for adults who are overweight or obese but do not have diabetes. Researchers want to understand how BGM0504 works in the body (pharmacokinetics and pharmacodynamics), if it shows any early signs of helping, and if it is safe and well-tolerated. You might be able to join if you are between 18 and 65 years old and have a Body Mass Index (BMI) that meets specific criteria for obesity or overweight with certain health conditions like prediabetes, high blood pressure, fatty liver, or high cholesterol. The main goal is to track any side effects over 11 weeks. The study is currently unclear on its recruitment status and plans to enroll about 80 participants.

Study design
This is a Phase 1, single-center study where participants will be randomly assigned to receive either BGM0504 or a placebo (an inactive substance). The study will involve different doses of BGM0504.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoint, which tracks adverse events, is measured at 11 weeks.

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NCT07166081

Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets in Non-diabetic Overweight or Obese Adult Subjects

Recruiting
PHASE1Ages 18–65InterventionalTreatment
BrightGene Bio-Medical Technology Co., Ltd.
~80 participants
Updated 2025-09-19 on ClinicalTrials.gov
What's tested:BGM0504Placebo

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 11 weeks

Conditions

Non-diabetic Overweight or Obese

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ObesityOverweight

Where it's being run

1 sites across 1 states
Maryland1

Who to contact

MB ChB
[email protected]
240-673-0900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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.

Exclusion

Have allergic predisposition (allergic to 3 or more foods or drugs), or are allergic to glucagon-like peptide-1 (GLP-1) receptor agonists or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis).
Have received GLP-1 receptor agonists or similar drugs containing the same target within 12 weeks before screening.
Have received drugs that have an impact on body weight within 12 weeks before screening.
Known type I/II diabetes.
History of acute or chronic pancreatitis or pancreatic injury.
History of drug abuse or alcoholism at screening.

What this trial measures

  • Number of treatment adverse events11 weeks

    The relationship of each adverse event tothe investigational product was assessed by the investigator