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A Study of BGM0504 in Participants with Type 2 Diabetes

NCT06716216 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 537

Last updated 2025-02-07

No results posted yet for this study

Summary

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

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Drug: 5 mg BGM0504 Administered SC

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

DRUG

Drug:10 mg BGM0504 Administered SC

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

DRUG

Drug: Semaglutide Administered SC

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

Sponsors & Collaborators

  • BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

    collaborator INDUSTRY

  • BrightGene Bio-Medical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-29
Primary Completion
2026-03-20
Completion
2026-11-14
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716216 on ClinicalTrials.gov