A Study of BGM0504 in Participants with Type 2 Diabetes

NCT06716216 · Recruiting

Last updated 2026-05-28

This clinical trial is testing the safety and effects of the investigational drug BGM0504 in adults with type 2 diabetes.

Status Recruiting Currently enrolling participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 537 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2024-11 · est. completion 2026-11

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT06716216 ↗

Description as written by the study sponsor.

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

Treatments tested

Drug: 5 mg BGM0504 Administered SC Drug

Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
Drug:10 mg BGM0504 Administered SC Drug

Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.
Drug: Semaglutide Administered SC Drug

Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week

Main thing measured	Change From Baseline in Hemoglobin A1c (HbA1c)
Sponsor	BrightGene Bio-Medical Technology Co., Ltd.
Conditions studied	Type 2 Diabetes Mellitus (T2DM)
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06716216 ↗