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NCT06716216Active, not recruitingPhase 3

A Study of BGM0504 in Participants With Type 2 Diabetes

A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin and/or Sulfonylureas in Patients With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 15 Oct 2026

Brief summary (registry, in English)

This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
537 (estimated)
First submitted
29 Nov 2024
Start date
13 Jan 2025
Primary completion date
14 Nov 2026
Lead sponsor
BrightGene Bio-Medical Technology Co., Ltd.
NCT number
NCT06716216

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 537
  • From 13 Jan 2025 to the primary completion date, 14 Nov 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • ■ Previous diagnosis of type 1 diabetes, special type diabetes;
    • There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
    • Have had chronic or acute pancreatitis any time prior to study entry;
    • Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
    • Mentally incapacitated or speech-impaired;
    • Suspected or confirmed history of alcohol or drug abuse;
    • Pregnant or lactating woman;
    • The investigator considers that there are any other conditions that make it inappropriate to participate in this study.

Who the study is looking for

  • ■ Have been diagnosed with type 2 diabetes mellitus (T2DM);
    • Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (\< 1500mg but≥1000mg daily) for 8 weeks before screening; 2)Metformin treatment dose \<1500mg/day at Screening and have not reached the maximum tolerated dose ;3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.
    • Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
    • Be of stable weight (± 5%) for at least 3 months before screening;
    • Have HbA1c between ≥7.5% and ≤11.0%;

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.