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Recruiting NCT07743983

A Study of BGM0504 in Early T2DM With Obesity

Phase III Interventional Type 2 Diabetes (T2DM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BGM0504, semaglutide.
Who it may be relevant to
Registry conditions: Type 2 Diabetes (T2DM). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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）

Overview

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.

Interventions

  • Drug BGM0504
    Administered as a subcutaneous injection once weekly for 52 weeks.
  • Drug semaglutide
    Administered as a subcutaneous injection once weekly for 52 weeks.

Primary outcome measures

  • Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline [Time frame: Week 52]
Secondary outcome measures (12)
  • Proportion of Participants Achieving Diabetes Remission [Time frame: Week 64 (12 weeks off treatment)]
  • Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline [Time frame: Weeks 12, 24, 36, 44]
  • Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline [Time frame: Weeks 12, 24, 36, 44, 52]
  • Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%) [Time frame: 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 [Time frame: Weeks 12, 24, 36, 44, 52]
  • Proportion of Participants Achieving Glycemic and Weight Targets at 12 Weeks Off Treatment [Time frame: Week 64]
  • Change from Baseline in HbA1c [Time frame: Weeks 12, 24, 36, 44, 52]
  • Change from Baseline in Fasting Plasma Glucose (FPG) [Time frame: Weeks 12, 24, 36, 44, 52]
  • Change from Baseline in 2-Hour Postprandial Glucose [Time frame: Week 52]
  • Change from Baseline in Body Weight [Time frame: Weeks 12, 24, 36, 44, 52]
  • Change from Baseline in BMI [Time frame: Weeks 12, 24, 36, 44, 52]
  • Change from Baseline in Waist Circumference and Hip Circumference [Time frame: Weeks 12, 24, 36, 44, 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School） — Nanjing

Identifiers

NCT: NCT07743983 · BGM0504-Ⅲ -T2DM-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗