BGM0504 for Obesity

Overseen By MB ChB

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Must not be taking: GLP-1 agonists, Weight-loss drugs

Disqualifiers: Diabetes, Pancreatitis, Drug abuse, others

Compensation: Varies

Number of Visits: Unknown

Duration: 11 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BGM0504, administered as a daily pill, to evaluate its effects and safety in individuals who are overweight or obese but do not have diabetes. Participants will receive varying doses of BGM0504 or a placebo to help researchers understand the treatment's effects and side effects. The trial seeks individuals with a stable weight and a BMI indicating they are overweight or obese, possibly with conditions like prediabetes or high blood pressure. As a Phase 1 trial, this research aims to understand how BGM0504 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial does not specify if you need to stop taking your current medications, but you cannot have taken drugs affecting body weight or GLP-1 receptor agonists 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. For example, one study found that BGM0504 caused no major side effects, even at higher doses. Another study confirmed these results, suggesting that BGM0504 could be further developed for weight loss and type 2 diabetes due to its safety. Although this trial is in its early stages, previous research on BGM0504 offers a positive outlook on its safety for participants. ^{1 2 3 4 5}

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

BGM0504 is unique because it offers a fresh approach to tackling obesity by potentially targeting specific metabolic pathways differently than current options like appetite suppressants or fat absorption inhibitors. Unlike existing treatments, BGM0504 is administered in varying doses, ranging from 20 mg to 80 mg, allowing researchers to fine-tune its effectiveness and safety across different levels. Researchers are excited about this drug because it represents a novel oral treatment option that could provide more personalized and potentially more effective weight management strategies.

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

Research has shown that BGM0504 may aid in weight management. In a study with 120 obese patients, those who received the treatment lost more weight than those who took a placebo, a harmless pill with no active ingredients. BGM0504 activates specific parts of the body that regulate hunger and energy use. Previous studies also suggest it might reduce health risks associated with obesity. Overall, these findings indicate that BGM0504 could effectively manage obesity. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for non-diabetic adults who are overweight or obese, with a stable body weight and BMI within certain ranges. They must not have a history of pancreatitis, severe allergies including to GLP-1 receptor agonists, diabetes, drug abuse or alcoholism. Participants should not have used weight-affecting drugs recently.

Inclusion Criteria

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

My BMI is between 27 and 40, and I may have prediabetes, high blood pressure, fatty liver, or abnormal cholesterol levels.

I understand and agree to the study's requirements.

Exclusion Criteria

I have had pancreatitis or injury to my pancreas.

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)

Known type I/II diabetes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending doses of BGM0504 or placebo to evaluate pharmacokinetics, pharmacodynamics, safety, and tolerability

11 weeks

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 BGM0504 tablets against placebo in overweight or obese adults. It's designed to understand how the body processes the drug (PK), its effects on the body (PD), safety, tolerability and initial effectiveness through daily doses.

How Is the Trial Designed?

Group I: Cohort 4 Experimental Treatment 1 Intervention

80mg BGM0504 administered orally

Group II: Cohort 3 Experimental Treatment 1 Intervention

60 mg BGM0504 administered orally

Group III: Cohort 2 Experimental Treatment 1 Intervention

40 mg BGM0504 administered orally

Group IV: Cohort 1 Experimental Treatment 1 Intervention

20 mg BGM0504 administered orally

Group V: Placebo Placebo Group 1 Intervention

Placebo administered orally

Who Is Running the Clinical Trial?

BrightGene Bio-Medical Technology Co., Ltd.

Lead Sponsor

Trials

3

Recruited

770+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06704581

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 behavioral ...

2. nature.com nature.com/articles/s41598-024-66998-8

Molecular dynamics-guided optimization of BGM0504 ... As a dual agonist targeting GLP-1R/GIPR, Tirzepatide has demonstrated significant effectiveness in treating obesity and overweight. In recent ...

3. biospace.com biospace.com/press-releases/brightgene-presents-positive-phase-2-data-for-dual-glp-1r-gipr-agonist-for-weight-management-and-type-2-diabetes-and-preclinical-data-for-novel-amylin-analog-at-american-diabetes-associations-85th-scientific-sessions

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 ...

4. firstwordpharma.com firstwordpharma.com/story/5975593

ADA25: BrightGene's GLP-1/GIP agonist shows mettle in ... In a separate trial of 120 obese Chinese patients, BGM0504 across all three dose levels demonstrated significant placebo-adjusted reductions in ...

5. diabetesjournals.org diabetesjournals.org/diabetes/article/73/Supplement_1/849-P/156353/849-P-Safety-Tolerability-Pharmacokinetics-PK-and

849-P: Safety, Tolerability, Pharmacokinetics (PK), and ... Conclusions: BGM0504 was well tolerated with favorable PK profile and led to evident body weight loss. These data support further clinical ...

6. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/744-P/158588

744-P: Efficacy and Safety of BGM0504 in Chinese Patients ... This study evaluated the safety and efficacy of BGM0504 in Chinese patients with obesity during multiple-dose administration (s.c. injection).

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06911203

A Study of BGM0504 in Participants With Obesity To evaluate the efficacy and safety of BGM0504 compared with Tirzepatide in adult participants who have obesity without diabetes after 26 weeks of treatment.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39840511/

A dose-escalation Phase I study BGM0504 was generally safe and well tolerated with favourable PK profile and potential role in weight loss was also confirmed.

9. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/abs/10.1111/dom.16203

The safety, tolerability, pharmacokinetics and ... BGM0504 was generally safe ... These findings support subsequent development of BGM0504 for type 2 diabetes mellitus (T2DM) and obesity.