Testing BGM0504 tablets for weight and metabolic effects in non‑diabetic adults who are overweight or obese

A Phase 1, Double-Blind, Randomized, Ascending-Dose, Placebo-Controlled, Multiple-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Tablets Orally Administered in Non-diabetic Overweight or Obese Adult Subjects

This study will give daily BGM0504 tablets to see how the body processes them and whether they change weight or metabolic measures in non‑diabetic adults who are overweight or obese.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: BrightGene Bio-Medical Technology Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT07166081 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, single-center, randomized, placebo-controlled, ascending-dose study of daily oral BGM0504 in non-diabetic adults who are overweight or obese. The trial will measure pharmacokinetics and pharmacodynamics, record preliminary signs of efficacy on weight and metabolic markers, and monitor safety and tolerability. Participants will be assigned to receive ascending doses of BGM0504 or placebo and undergo regular clinic visits for blood sampling and clinical assessments. Key enrollment criteria include specific BMI ranges and stable body weight prior to screening.

Who should consider this trial

Good fit: Ideal candidates are non-diabetic adults with BMI 30.0–40.0 kg/m2 or BMI 27.0–29.9 kg/m2 with at least one related condition (prediabetes symptoms, grade 1 hypertension, simple fatty liver, or dyslipidemia) and stable weight (<5% change) in the prior 12 weeks who can attend the Baltimore clinic and consent to the protocol.

Not a fit: People with diabetes, those outside the BMI/clinical criteria, those with severe allergic predispositions, or those who have previously used GLP-1 receptor agonists are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BGM0504 could offer an oral option that improves weight and metabolic markers for non-diabetic people with overweight or obesity.

How similar studies have performed: Related drug classes (oral and injectable GLP-1 receptor agonists) have shown success in reducing weight and improving metabolic markers in later trials, but BGM0504 itself is in early-phase testing and currently unproven.

Eligibility criteria

Inclusion Criteria:

* Body mass index (BMI) meeting one of the following requirements:

  1. Between ≥ 30.0 kg/m2 and ≤ 40.0 kg/m2 (obese); 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
* 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 Criteria:

* 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.

Where this trial is running

Baltimore, Maryland

• Pharmaron CPC, Inc — Baltimore, Maryland, United States (Recruiting)

Study contacts

• Study coordinator: MB ChB

Conditions Non-diabetic Overweight or Obese