Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT07064486

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

Led by BrightGene Bio-Medical Technology Co., Ltd. · Updated on 2025-10-28

477

Participants Needed

4

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with type 2 diabetes mellitus
  • On stable metformin treatment (≥1500 mg/day or <1500 mg/day but ≥1000 mg/day) for at least 8 weeks before screening
  • Body mass index (BMI) of 23 kg/m² or higher at screening
  • Stable weight (±5%) for at least 3 months before screening
  • HbA1c between 7.5% and 11.0% at screening
Not Eligible

You will not qualify if you...

  • Previous diagnosis of type 1 diabetes or special type diabetes
  • History of cancer within the past 5 years, except cured basal cell carcinoma of the skin or cervical carcinoma in situ, or being evaluated for cancer
  • Acute or chronic pancreatitis
  • Allergic to three or more foods or medications, or allergic to GLP-1 agonist or metformin, or have severe allergic diseases such as asthma, urticaria, or eczematous dermatitis at screening
  • Serious mental illness or speech impediment preventing full understanding of the study
  • Suspected or confirmed history of alcohol or drug abuse
  • History of two or more severe hypoglycemic episodes in the past year
  • Other conditions that may affect assessment of study treatments, as determined by the Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

RS Universitas Indonesia

Depok, West Java, Indonesia

Actively Recruiting

2

RSUP Fatmawati

Jakarta, Indonesia

Actively Recruiting

3

RSUP Persahabatan

Jakarta, Indonesia

Actively Recruiting

4

RSUPN Dr. Cipto Mangunkusumo

Jakarta, Indonesia

Actively Recruiting

Loading map...

Research Team

T

Tahapary

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here