Status:

RECRUITING

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

Lead Sponsor:

BrightGene Bio-Medical Technology Co., Ltd.

Collaborating Sponsors:

BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

Conditions:

Type 2 Diabetes Mellitus (T2DM)

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief 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 co...

Eligibility Criteria

Inclusion Criteria:

  • ☑ Have been diagnosed with type 2 diabetes mellitus (T2DM);

    • Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
    • Be of stable weight (± 5%) for at least 3 months before screening;
    • Have HbA1c between ≥7.5% and ≤11.0%;
    • Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.

Exclusion Criteria:

  • ■ Previous diagnosis of type 1 diabetes, special type diabetes ;

    • There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
    • Have had chronic or acute pancreatitis any time prior to study entry;
    • Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
    • Mentally incapacitated or speech-impaired;
    • Suspected or confirmed history of alcohol or drug abuse;
    • Pregnant or lactating woman;
    • The investigator considers that there are any other conditions that make it inappropriate to participate in this study.

Key Trial Info

Start Date :

December 2 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 25 2026

Estimated Enrollment :

207 Patients enrolled

Trial Details

Trial ID

NCT06716203

Start Date

December 2 2024

End Date

August 25 2026

Last Update

February 7 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

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