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

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Drug: 5 mg BGM0504 Administered SC; Drug: Drug: Placebo Administered SC; Drug: Drug: : 10 mg BGM0504 Administered SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06716203

BGM0504-Ⅲ -T2DM-01

Details and patient eligibility

About

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.

Enrollment: 207 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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207 participants in 3 patient groups, including a placebo group

Experimental: 5 mg BGM0504

Experimental group

Description:

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

Treatment:

Drug: Drug: 5 mg BGM0504 Administered SC

Experimental: 10 mg BGM0504

Experimental group

Description:

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

Treatment:

Drug: Drug: : 10 mg BGM0504 Administered SC

Placebo Comparator: Placebo

Placebo Comparator group

Description:

Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Treatment:

Drug: Drug: Placebo Administered SC