A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia

BrightGene Bio-Medical Technology Co., Ltd.

Status and phase: Enrolling; Phase 3

Conditions: Type 2 Diabetes (T2DM)

Treatments: Drug: BGM0504; Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07064486

BGM0504-Ⅲ-T2DM-02-IDN

Details and patient eligibility

About

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

Enrollment: 477 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);

  • Be on stable treatment with unchanged dose of metformin ≥1500 mg/day or <1500 mg/day but ≥1000 mg/day (the maximum tolerated dose) for at least 8 weeks prior to screening
  • 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% at screening

Exclusion criteria

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

  • Have suffered the malignancy within the past 5 years (except cured basal cell carcinoma of the skin, cervical carcinoma in situ), or being evaluated for an underlying malignancy;
  • Have the acute or chronic pancreatitis;
  • Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist or metformin, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening;
  • Have a serious mental illness or speech impediment and be unable to fully understand the study;
  • Suspected or confirmed history of alcohol or drug abuse;
  • Have had a history of ≥2 severe hypoglycemic episodes in the past 1 year;
  • Other conditions that may impact the assessment of investigational products, as determined by the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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477 participants in 3 patient groups

5 mg BGM0504

Experimental group

Description:

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

Treatment:

Drug: BGM0504

Drug: BGM0504

10 mg BGM0504

Experimental group

Description:

10 mg BGM0504 administered SC once a week.

Treatment:

Drug: BGM0504

Drug: BGM0504

1 mg Semaglutide

Active Comparator group

Description:

1 mg semaglutide administered SC once a week

Treatment:

Drug: Semaglutide