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Study identifier: NCT06716216 Synced from ClinicalTrials.gov · August 11, 2026
● Study status: Recruiting

A Study of BGM0504 in Participants with Type 2 Diabetes

Condition: Type 2 Diabetes Mellitus (T2DM)  ·  Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

PhasePhase 3
Planned participants537
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNoCheck eligibility criteria ↓
WhereBeijing, Beijing Municipality, China

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Linong Ji,MD, chief physician, Peking University People's Hospital  ·  +86 13910978815  ·  jiln@bjmu.edu.cn

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * ■ 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%; Exclusion Criteria: * ■ 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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (1)

Peking University People's HospitalBeijing, Beijing Municipality, ChinaRecruiting

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Beijing

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