Clinical trial

A Study of BGM0504 in Participants with Type 2 Diabetes

Recruiting now · Phase 3 · 1 countries · Registry ID NCT06716216

Recruiting nowPhase 3Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionType 2 Diabetes Mellitus (T2DM)

Full registry criteria

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.

Treatments and study arms

Drug: 5 mg BGM0504 Administered SC

Drug

Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.

Drug:10 mg BGM0504 Administered SC

Drug

Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.

Drug: Semaglutide Administered SC

Drug

Active Comparator: 1 mg Semaglutide 1 mg semaglutide administered SC once a week

Primary outcomes

Change From Baseline in Hemoglobin A1c (HbA1c)Week 0 to Week 32

Change from baseline in HbA1c after 32 weeks of treatment.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Peking University People's Hospital🇨🇳 Beijing, Beijing Municipality, China
Linong JiContact