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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

477 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-04

Study Completion Date

2026-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Type 2 Diabetes (T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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5 mg BGM0504

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

Group Type EXPERIMENTAL

BGM0504

Intervention Type DRUG

Administered SC

10 mg BGM0504

10 mg BGM0504 administered SC once a week.

Group Type EXPERIMENTAL

BGM0504

Intervention Type DRUG

Administered SC

1 mg Semaglutide

1 mg semaglutide administered SC once a week

Group Type ACTIVE_COMPARATOR

Semaglutide

Intervention Type DRUG

Administered SC

Interventions

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BGM0504

Administered SC

Intervention Type DRUG

BGM0504

Administered SC

Intervention Type DRUG

Semaglutide

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No