BGM0504 for Obesity

Overseen By Charmagne G Beckett, MD, MPH, FACP

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: 10

Duration: 10 weeks

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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.

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?

Group I: Experimental: 15 mg BGM0504 15 mg BGM0504 administered SC once a week. Experimental Treatment 1 Intervention

Drug: BGM0504 Administered SC

Group II: Experimental: 10 mg BGM0504 10 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. Experimental Treatment 1 Intervention

Drug: BGM0504 Administered SC

Group III: Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week. Placebo Group 1 Intervention

Drug: Placebo Administered SC

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 279 patients with severe obesity (BMI ≥ 50 kg/m2) and type 2 diabetes, 47% achieved long-term remission of diabetes (≥ 5 years) after undergoing either Roux-En-Y gastric bypass (RYGB) or sleeve gastrectomy (SG).

Key factors influencing long-term remission included the duration of diabetes, the number of diabetes medications taken, and the amount of weight lost, highlighting the importance of these variables in predicting successful outcomes after bariatric surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Mellitus Remission in Patients with BMI&#8201;&gt;&#8201;50&#160;kg/m2 after Bariatric Surgeries: A Real-World Multi-Centered Study. Ghusn, W., Ikemiya, K., Al Annan, K., et al.[2023]

In a study of 129 patients with severe obesity (BMI ≥ 40 kg/m²), semaglutide 2.4 mg treatment led to a significant average weight loss of 9.1% over 24 weeks, showing its effectiveness in this population.

There was no significant difference in weight loss between patients who had previously undergone bariatric surgery and those who had not, indicating that semaglutide can be a viable treatment option for both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4 mg/wk for weight loss in patients with severe obesity and with or without a history of bariatric surgery. Bonnet, JB., Tournayre, S., Anitcheou, J., et al.[2023]

Liraglutide, a GLP-1 receptor agonist, is effective for weight loss in overweight or obese patients, showing greater weight reduction compared to placebo and orlistat, particularly at a dosage of 3 mg daily.

In addition to weight loss, liraglutide has been associated with significant health improvements, including reductions in waist circumference, blood pressure, and better lipid profiles, making it a beneficial option for patients with or without type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide, GLP-1 receptor agonist, for chronic weight loss. Moore, KG., Shealy, K., Clements, JN.[2022]

Semaglutide has been studied in several key clinical trials (SUSTAIN, PIONEER, and STEP) for its effectiveness in treating obesity and type 2 diabetes, highlighting its potential as a significant intervention for these conditions.

Obesity is a major health issue, with 26.2% of the population in the Russian Federation classified as obese, which increases the risk of serious health problems like diabetes and hypertension, underscoring the importance of effective treatments like semaglutide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide - effectiveness in weight loss and side effects when used according to studies by SUSTAIN, PIONEER, STEP]. Shabutdinova, OR., Dautov, AR., Samkov, AA., et al.[2023]

Laparoscopic adjustable gastric banding (LAGB) led to significant weight loss in 172 obesity patients over 48 months, with a mean body mass index (BMI) reduction from 38.5 kg/m² to 28.1 kg/m² and over 62% excess weight loss achieved by the end of the study.

The procedure also resulted in substantial improvements in obesity-related comorbidities, including diabetes control in 60.7% of patients, normalization of blood pressure in 22 hypertensive patients, and resolution of sleep apnea symptoms in 29 patients, all with minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Laparoscopic adjustable gastric banding in the treatment of obesity: analysis of 172 cases]. Ji, XR., Chen, DL., Hu, XG., et al.[2019]

Semaglutide, approved by the FDA on June 4, 2021, is the first new drug for chronic weight management in adults with obesity or overweight since 2014, specifically targeting those with a BMI of 27 or greater and at least one weight-related condition.

This medication is intended to be used alongside a weight management program that includes a reduced-calorie diet and increased physical activity, highlighting its role as part of a comprehensive approach to weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for weight loss and cardiometabolic risk reduction in overweight/obesity. Mares, AC., Chatterjee, S., Mukherjee, D.[2023]

Bariatric surgery is more effective for weight loss than lifestyle changes or medications alone, with expected weight loss ranging from 37% to 79% of excess weight within 2 years, depending on the type of surgery performed.

Candidates for surgery typically have a body mass index (BMI) of 40 or higher, or a BMI of 35 with obesity-related health issues, and must commit to lifelong dietary monitoring to prevent nutritional deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity: surgical management. Vesely, JM., DeMattia, LG.[2019]

Bariatric procedures are confirmed to be safe and effective interventions for higher-risk patients with obesity, supported by updated clinical practice guidelines that include 85 recommendations based on new evidence from 2013 to the present.

The guidelines emphasize the importance of evidence-based clinical decision-making within the context of obesity as a chronic disease, highlighting the need for a team approach to perioperative care that addresses nutritional and metabolic issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CLINICAL PRACTICE GUIDELINES FOR THE PERIOPERATIVE NUTRITION, METABOLIC, AND NONSURGICAL SUPPORT OF PATIENTS UNDERGOING BARIATRIC PROCEDURES - 2019 UPDATE: COSPONSORED BY AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS/AMERICAN COLLEGE OF ENDOCRINOLOGY, THE OBESITY SOCIETY, AMERICAN SOCIETY FOR METABOLIC &amp; BARIATRIC SURGERY, OBESITY MEDICINE ASSOCIATION, AND AMERICAN SOCIETY OF ANESTHESIOLOGISTS - EXECUTIVE SUMMARY. Mechanick, JI., Apovian, C., Brethauer, S., et al.[2021]

In a study of 131 young obese patients who underwent bariatric surgery, significant improvements in body weight, blood pressure, fasting plasma glucose, HbA1c, and triglyceride levels were observed within one to three months post-surgery.

Age and pre-operative HbA1c levels were identified as key predictors for HbA1c reduction, while pre-operative body weight was a strong predictor for weight loss, highlighting the importance of these factors in post-surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rapid Changes in Bodyweight and Glycemic Control Are Determined by Pre-status After Bariatric Surgery in Both Genders in Young Chinese Individuals. Wen, S., Gong, M., Wang, T., et al.[2023]

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A dose-escalation Phase I study

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The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and ...

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