RecruitingPhase 3NCT06716203

A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone


Sponsor

BrightGene Bio-Medical Technology Co., Ltd.

Enrollment

207 participants

Start Date

Dec 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise. The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.


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, similar to medications like Ozempic) in people with type 2 diabetes whose blood sugar is not well-controlled through diet and exercise alone (without any diabetes medications). The goal is to assess how safely and effectively it lowers blood sugar. **You may be eligible if...** - You have type 2 diabetes managed only with diet and exercise - Your HbA1c is between 7.5% and 11.0% - Your BMI is 23 or above - Your weight has been stable 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 (pancreas inflammation) - You are allergic to GLP-1 receptor agonist medications - 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

Drug: BGM0504 Administered SC

DRUGDrug: : 10 mg BGM0504 Administered SC

Drug: BGM0504 Administered SC

DRUGDrug: Placebo Administered SC

Drug: Placebo Administered SC


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06716203


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