RecruitingPhase 3NCT06716216

A Study of BGM0504 in Participants with Type 2 Diabetes

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And/or Sulfonylureas in Patients with Type 2 Diabetes


Sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Enrollment

537 participants

Start Date

Nov 29, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BGM0504 (a GLP-1 receptor agonist) in people with type 2 diabetes who are already taking metformin (with or without a sulfonylurea) but still have poor blood sugar control. It aims to see whether BGM0504 improves blood sugar levels safely. **You may be eligible if...** - You have type 2 diabetes - You are on a stable dose of metformin (or metformin plus a sulfonylurea) for at least 8 weeks - Your HbA1c is between 7.5% and 11.0% - Your BMI is 23 or above - Your weight has been stable (within ±5%) for at least 3 months **You may NOT be eligible if...** - You have type 1 diabetes - You have had cancer in the past 5 years (some exceptions apply) - You have had pancreatitis - You are allergic to GLP-1 receptor agonists - You are pregnant or breastfeeding - You have a history of alcohol or substance abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDrug: 5 mg BGM0504 Administered SC

Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

DRUGDrug:10 mg BGM0504 Administered SC

Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.

DRUGDrug: Semaglutide Administered SC

Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06716216


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