A Study of BGM0504 in Early T2DM With Obesity

A Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）

This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes (T2DM)
• Intervention / Treatment: Drug: BGM0504; Drug: semaglutide

• Study Type: Interventional
• Enrollment (Estimated): 372
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhu; Phone Number: +86025-68182432; Email: zhudalong@nju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School）

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening.

  • BMI 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening.
  • Have HbA1c between ≥7.5% and ≤10.5% at screening.
  • FPG ≤15.0 mmol/L at screening.
  • If hypertensive: SBP <180 mmHg and DBP <110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks.
  • Willing to comply with protocol, use effective contraception, and provide informed consent.

Exclusion Criteria:

• ● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.

  • Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months.
  • History of acute/chronic pancreatitis.
  • Medullary thyroid carcinoma, MEN 2A/2B, or family history.
  • Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence).
  • Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias.
  • Hemorrhagic or ischemic stroke within 6 months.
  • Severe renal disease or eGFR ≤60 mL/min/1.73 m² (CKD-EPI).
  • Pregnant or lactating woman.
  • Prior clinical trial participation with investigational drug or device within 3 months.
  • Other situations that are deemed as inappropriate for participation by investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BGM0504 Injection 15 mg	Drug: BGM0504; Administered as a subcutaneous injection once weekly for 52 weeks.
Active Comparator: Semaglutide Injection 1.0 mg	Drug: semaglutide; Administered as a subcutaneous injection once weekly for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline	Composite endpoint assessing both glycemic control and weight loss.	Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Diabetes Remission	Defined as HbA1c < 6.5% without use of glucose-lowering medications.	Week 64 (12 weeks off treatment)
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline	Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.	Weeks 12, 24, 36, 44
Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline	Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.	Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)	Glycemic control assessed at each visit.	Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline	Composite endpoint assessing stricter glycemic targets combined with weight loss.	Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment	Composite of HbA1c < 5.7% or < 6.5% with weight reduction ≥ 5% or ≥ 10%, assessing durability of response after treatment withdrawal.	Week 64
Change from Baseline in HbA1c	Absolute change in glycated hemoglobin from baseline.	Weeks 12, 24, 36, 44, 52
Change from Baseline in Fasting Plasma Glucose (FPG)	Absolute change in fasting glucose from baseline.	Weeks 12, 24, 36, 44, 52
Change from Baseline in 2-Hour Postprandial Glucose	Glucose measured 2 hours after a standard meal, absolute change from baseline.	Week 52
Change from Baseline in Body Weight	Absolute and percentage change in body weight	Weeks 12, 24, 36, 44, 52
Change from Baseline in BMI	Absolute and percentage change in BMI (kg/m²).	Weeks 12, 24, 36, 44, 52
Change from Baseline in Waist Circumference and Hip Circumference	Absolute change in waist and hip circumference from baseline.	Weeks 12, 24, 36, 44, 52
Proportion of Participants Achieving Weight Reduction ≥ 5%, 10%, 15%, and 20% from Baseline	Categorical weight loss responders at multiple thresholds.	Weeks 12, 24, 36, 44, 52
Percentage Change from Baseline in Lipid Profile (TC, TG, LDL-C, HDL-C)	Percentage change in total cholesterol, triglycerides, LDL-C, and HDL-C from baseline.	Weeks 12, 24, 36, 44, 52
Change from Baseline in Systolic and Diastolic Blood Pressure (SBP/DBP)	Absolute change in seated SBP and DBP from baseline.	Weeks 12, 24, 36, 44, 52
Incidence of Treatment-Emergent Adverse Events (TEAEs)	Includes adverse events, serious adverse events, and hypoglycemic events.	Baseline to 64 weeks

Collaborators and Investigators

• Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: July 24, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; semaglutide
• Other Study ID Numbers: BGM0504-Ⅲ -T2DM-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No