BGM1812 for Obesity

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: Amylin agonists

Disqualifiers: Diabetes, Severe allergies, Pancreatitis, others

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores BGM1812, a potential drug for individuals who are overweight or obese but otherwise healthy. The trial aims to understand how the body processes the drug, its initial effectiveness, and its safety. Participants will receive either the actual treatment or a placebo for comparison. Ideal candidates have a stable weight and a BMI over 23; those who are overweight may also have mild health issues like prediabetes or high blood pressure. Participants should not have diabetes or a history of certain surgeries. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that BGM1812 is likely to be safe for humans?

Research has shown that BGM1812 could be a promising treatment for obesity. In early lab tests, it activated certain receptors and led to weight loss, demonstrating effectiveness before human testing.

This is a Phase 1 study, with the main goal of determining if BGM1812 is safe for human use. Detailed safety information for humans is not yet available. The study examines how the body processes the drug and identifies any side effects. Phase 1 studies involve close monitoring to quickly detect any issues.

As BGM1812 undergoes its first human testing, participants will help researchers understand its safety. The existing data is promising, but this trial will provide the first clear evidence of how people handle BGM1812. ^{1 2 3 4 5}

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

BGM1812 is unique because it introduces a new approach to managing obesity by using single and multiple ascending doses administered subcutaneously. Unlike many current treatments that often involve oral medications or lifestyle changes, BGM1812's subcutaneous delivery could offer more direct and potentially faster effects. Researchers are excited about BGM1812 because it might target obesity in a novel way, which could lead to significant advancements in how we approach weight management.

What evidence suggests that BGM1812 might be an effective treatment for obesity?

Research has shown that BGM1812, a new type of medication, may aid in weight loss. In this trial, participants will receive either single or multiple ascending doses of BGM1812, or a placebo. Studies have found that higher doses of BGM1812 correlate with greater weight loss. At a certain dose, BGM1812 resulted in more weight loss than another similar drug. It also helped individuals lose weight without losing muscle. These findings suggest BGM1812 could be a useful treatment for obesity. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for normal to overweight or obese men and women who are generally healthy. Specific details about age, previous conditions, medications, or lifestyle factors that would qualify or disqualify someone from participating are not provided.

Inclusion Criteria

Body mass index (BMI) meeting specific requirements based on different cohorts

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

I understand and agree to the study's requirements.

Exclusion Criteria

Has any other conditions or disorders deemed unsuitable for including in the study, in the opinion of the Investigator

Known type I/II diabetes

I am allergic to multiple substances or have severe allergies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single ascending doses of BGM1812 or placebo administered subcutaneously

7 weeks

Multiple visits for dose administration and monitoring

Treatment Part B

Multiple ascending doses of BGM1812 or placebo administered subcutaneously

13 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BGM1812

Trial Overview The study is testing BGM1812, a new medication given by injection under the skin (subcutaneous). It's compared with a placebo in a controlled setting to see how the body absorbs it (pharmacokinetics), its effects on the body (pharmacodynamics), safety, and tolerability.

How Is the Trial Designed?

Group I: BGM1812 (Part B) Experimental Treatment 1 Intervention

Multiple ascending doses of BGM1812 administered SC.

Group II: BGM1812 (Part A) Experimental Treatment 1 Intervention

Single ascending doses of BGM1812 administered subcutaneously (SC).

Group III: Placebo (Part A) Placebo Group 1 Intervention

Placebo administered SC.

Group IV: Placebo (Part B) Placebo Group 1 Intervention

Placebo administered SC.

Who Is Running the Clinical Trial?

BrightGene Bio-Medical Technology Co., Ltd.

Lead Sponsor

Trials

3

Recruited

770+

Citations

1. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/1993-LB/158650/1993-LB-BGM1812-a-Novel-Amylin-Analog-Enhances

1993-LB: BGM1812, a Novel Amylin Analog, Enhances ... Enhanced weight loss: BGM1812 demonstrated dose-dependent weight loss in 0.012 - 0.12 mg/kg dose range. At 0.04 mg/kg, BGM1812 induced greater ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40608546/

Discovery of BGM1812, a Novel Dual Amylin and ... In both in vivo and in vitro studies, BGM1812 showed significantly enhanced efficacy. ... BGM1812 as a promising obesity drug candidate.

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 ... At 0.04 mg/kg, BGM1812 achieved greater weight reduction than petrelintide. In addition, BGM1812 significantly preserved relative lean mass ...

4. clival.com clival.com/news/fda-clears-pearlmatrix-as-first-lumbar-fusion-accelerator

FDA clears PearlMatrix as first lumbar fusion accelerator ... overweight and obese non-diabetic individuals. Preclinical data for BGM1812 demonstrated superior receptor activation, robust weight loss ...

5. researchgate.net researchgate.net/publication/393379853_Discovery_of_BGM1812_a_Novel_Dual_Amylin_and_Calcitonin_Receptor_Agonist_for_Obesity_Treatment

Discovery of BGM1812, a Novel Dual Amylin and ... The ideal anti-obesity drug would produce sustained weight loss with minimal side effects. The mechanisms that regulate energy balance have substantial built-in ...

6. finance.yahoo.com finance.yahoo.com/news/brightgene-presents-positive-phase-2-005400848.html

BrightGene Presents Positive Phase 2 Data for Dual GLP ... Preclinical data for BGM1812 demonstrated superior receptor activation, robust weight loss and synergistic potential with GLP-1/GIP dual agonism ...

7. synapse.patsnap.com synapse.patsnap.com/drug/f5b751e9a90644f8b43d3667b0e55dda

BGM1812 - Drug Targets, Indications, Patents A Phase 1, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 ...