Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing BGM0504 for Type 2 Diabetes (T2DM)

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, how well it works and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.

Official registry: https://clinicaltrials.gov/study/NCT07743983 · BrightGene Bio-Medical Technology Co., Ltd. · enrollment listed as 372

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are BGM0504, or semaglutide. The registry lists allocation as randomized. 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.

They plan to enroll about 372 people at Nanjing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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）

Interventions: BGM0504, semaglutide

Primary outcome (registry wording): Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline

Who it is for (from inclusion criteria)

  • Ages 18 Years to 75 Years
  • ○ 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
  • body-mass index (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

Public study contact (from the registry)

Zhu

+86025-68182432

zhudalong@nju.edu.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT07743983 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07743983?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07743983?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary