BGM0504 vs. semaglutide in Chinese adults with obesity-related T2DM

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3 interventional study conducted in Nanjing, China. Eligible adults have type 2 diabetes of short duration, obesity, and limited prior antidiabetic therapy, and meet specific blood pressure and lab criteria. Participants will receive either BGM0504 15 mg weekly or semaglutide 1.0 mg weekly for 52 weeks, with ongoing safety and efficacy assessments. A key exploratory endpoint is the rate of diabetes remission 12 weeks after the end of treatment. The study design focuses on comparative effectiveness and tolerability in a real-world obesity-T2DM population. Data from this trial could inform future treatment options for patients with similar profiles.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Zhu
• Email: zhudalong@nju.edu.cn
• Phone: +86025-68182432

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pancreatin Added to Standard Diabetes Therapy

  Researchers are testing whether adding pancreatin helps people with type 2 diabetes see better blood sugar control when they already take oral meds or insulin.

  Recruiting Phase 4 Silesian Centre for Heart Diseases · Zabrze, Silesian Voivodeship · NCT07852988

• Health for Hungary: Long-term blood and health data collection to study aging and disease onset

  This study tests whether routine blood tests plus advanced molecular analyses can help detect the early stages of non-communicable diseases in adults over 40.

  Recruiting at 21 sites Center for Molecular Fingerprinting Research Nonprofit LLC · Balatonfüred and 32 other locations · NCT07743021

• Real-Time Glucose Monitoring in Newly Diagnosed Type 2 Diabetes

  This study tests whether real-time glucose monitoring helps people with newly diagnosed type 2 diabetes manage glucose better than traditional finger-prick testing.

  Recruiting at 2 sites Bogomolets National Medical University · Kyiv and 2 other locations · NCT07690163

• Cinematic virtual reality to improve geriatric care training for osteopathic medical students.

  This project will test whether cinematic virtual reality training helps osteopathic medical students learn geriatric care better than traditional lectures.

  Recruiting Ohio University · Athens, Ohio · NCT07542834

• GZR33 Injection plus Insulin Degludec for Type 2 Diabetes in Need of More Control

  This study tests whether daily GZR33 injection plus daily Insulin Degludec can help adults with type 2 diabetes who aren’t adequately controlled by pills.

  Recruiting Phase 3 Gan & Lee Pharmaceuticals. · Beijing · NCT07527078

• Vitamin D to Help Blood Sugar in People at Risk for Type 2 Diabetes

  This study tests whether weekly vitamin D, adjusted to reach a target blood level, can help control blood sugar in adults with prediabetes.

  Recruiting Phase 3 Tufts Medical Center · Boston, Massachusetts · NCT07448974

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.