BGM0504 for Obesity

CG
Overseen ByCharmagne G Beckett, MD, MPH, FACP
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called BGM0504 for individuals who are overweight or have obesity. The research will examine how the body processes this treatment, its effects, and any side effects. Participants will receive either the treatment or a placebo (a substance with no active drug) through a weekly injection. This trial may suit adults who are overweight or have obesity, maintain a stable weight, and might also have conditions like prediabetes, high blood pressure, or sleep apnea linked to their weight. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have taken GLP-1 receptor agonists or drugs affecting body weight within 12 weeks before screening.

Is there any evidence suggesting that BGM0504 is likely to be safe for humans?

Research has shown that BGM0504 is generally safe and well-tolerated by people with obesity. In earlier studies, participants who took BGM0504 handled it well, with most not experiencing serious side effects. Any minor side effects were manageable. These results suggest that BGM0504 could be a safe option for managing weight in overweight or obese individuals. However, as BGM0504 remains under study, ongoing research must continue to monitor its safety.12345

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about BGM0504 for obesity because it offers a new approach by being administered subcutaneously once a week. Unlike many existing treatments that often involve daily oral medications or lifestyle changes, BGM0504 could simplify the treatment process with its once-a-week injection. Additionally, with two different dosages being tested, 10 mg and 15 mg, there is potential for personalized treatment options based on patient needs. This novel delivery method and dosage flexibility could make managing obesity more convenient and effective for patients.

What evidence suggests that BGM0504 might be an effective treatment for obesity?

Research has shown that BGM0504 may aid in weight management and reduce health risks in overweight and obese individuals without diabetes. Studies suggest it could be effective for weight control. In this trial, participants will receive either 10 mg or 15 mg of BGM0504, or a placebo, administered subcutaneously once a week. Comparisons with Tirzepatide, a well-known weight-loss drug, have shown positive results for BGM0504. This treatment targets specific pathways in the body to help manage weight. Early findings indicate that BGM0504 could be a useful option for those struggling with obesity.13678

Are You a Good Fit for This Trial?

This trial is for non-diabetic adults who are overweight or obese. Participants will receive multiple doses of a new medication, BGM0504, to see how it's processed by the body and its effects on weight.

Inclusion Criteria

I understand and agree to the study's requirements.
Have a stable body weight (<5% self-reported change during the previous 8 weeks) before screening
My BMI is between 27 and 40, and I may have specific health conditions if it's between 27 and 30.

Exclusion Criteria

Allergic predisposition (allergic to 3 or more foods or drugs), allergic to glucagon-like peptide-1 (GLP-1) receptor agonists, or suffer from severe allergic diseases (asthma, urticaria, eczematous dermatitis)
I have taken medication that affects my weight in the last 3 months.
I have had surgery to help with weight loss.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple subcutaneous administrations of BGM0504 or placebo once a week

10 weeks
10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BGM0504
Trial Overview The study tests two different doses of BGM0504 (10 mg and 15 mg) against a placebo. Each treatment is given once a week through an injection under the skin in this double-blind study where neither participants nor researchers know who gets what.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week.Experimental Treatment1 Intervention
Group II: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.Experimental Treatment1 Intervention
Group III: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BrightGene Bio-Medical Technology Co., Ltd.

Lead Sponsor

Trials
3
Recruited
770+

Published Research Related to This Trial

The conference highlighted various innovative approaches to developing safe and effective obesity drugs, focusing on different neuroendocrine and peripheral tissue targets, which is crucial given the global obesity epidemic.
Key agents discussed included rimonabant, which has completed extensive phase III trials, and early-stage drugs like selective 5-HT(2C) agonists and synthetic analogs of gut hormones, indicating a diverse pipeline of potential treatments for obesity.
Obesity Drug Development Summit. 21-22 July, 2005, Arlington, VA, USA.Maggio, CA.[2007]
A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.
Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.
Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020.Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]
Semaglutide and tirzepatide, two new anti-obesity medications, can lead to significant weight loss—approximately 15% and up to 20.9% respectively—over 68 weeks, which is more effective than traditional lifestyle modifications that typically result in 5-10% weight loss.
These medications work by enhancing feelings of fullness and reducing hunger, potentially reducing the reliance on traditional weight loss strategies like monitoring food intake, but more research is needed to understand how they affect long-term healthy eating and activity habits.
The Role of Lifestyle Modification with Second-Generation Anti-obesity Medications: Comparisons, Questions, and Clinical Opportunities.Wadden, TA., Chao, AM., Moore, M., et al.[2023]

Citations

A Study of BGM0504 in Participants With ObesityTo evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.
Molecular dynamics-guided optimization of BGM0504 ...The results suggest the potential therapeutic efficacy of BGM0504 in obesity indications, though such implications fall beyond the scope of this ...
744-P: Efficacy and Safety of BGM0504 in Chinese Patients ...BGM0504 demonstrates significant potential for weight management and metabolic risk reduction in overweight and obese non-diabetic individuals.
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39030216/
Molecular dynamics-guided optimization of BGM0504 ...Tirzepatide, a dual agonist peptide, has exhibited superior clinical efficacy in glycemic and weight control compared to selective GLP-1R ...
BrightGene Presents Positive Phase 2 Data for Dual GLP ...Results from two separate Phase 2 studies in BGM0504 demonstrated significant potential for weight management and metabolic risk reduction in individuals with ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39840511/
A dose-escalation Phase I studyConclusion: BGM0504 was generally safe and well tolerated with favourable PK profile and potential role in weight loss was also confirmed. These ...
A Study of BGM0504 Injection in Participants with Obesity ...The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and ...
The safety, tolerability, pharmacokinetics and ...BGM0504 was generally safe ... These findings support subsequent development of BGM0504 for type 2 diabetes mellitus (T2DM) and obesity.
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