BGM0504 compared with semaglutide in early type 2 diabetes with obesity
Compares BGM0504 with semaglutide in adults with early type 2 diabetes and obesity.
Plain-language title generated from the registry record
Registry title: A Study of BGM0504 in Early T2DM With Obesity
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07743983, who can take part
Where in China
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BrightGene Bio-Medical Technology Co., Ltd.
- Trial code
- NCT07743983
- Record updated
- 13 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: ○ 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: ● 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.