A Study of BGM0504 in Participants with Type 2 Diabetes

Last updated: February 6, 2025
Sponsor: BrightGene Bio-Medical Technology Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

Drug: Semaglutide Administered SC

Drug:10 mg BGM0504 Administered SC

Drug: 5 mg BGM0504 Administered SC

Clinical Study ID

NCT06716216
BGM0504-Ⅲ -T2DM-02
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ■ Have been diagnosed with type 2 diabetes mellitus (T2DM);

  • Metformin is used in screening : 1) After used stable-dose metformin (≥1500mg/day) or maximum tolerated (< 1500mg but≥1000mg daily) for 8 weeks beforescreening; 2)Metformin treatment dose <1500mg/day at Screening and have notreached the maximum tolerated dose ;3) Metformin combined with daily fixed-dosesulfonylureas (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

Exclusion Criteria:

  • ■ Previous diagnosis of type 1 diabetes, special type diabetes;

  • There are malignant tumors within 5 years before screening, or patients are inlatent of clinical malignant tumors (except patients with skin basal cellcarcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostatecarcinoma in situ or papillary thyroid carcinoma who have no recurrence aftersurgery).

  • 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), orallergy 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 itinappropriate to participate in this study.

Study Design

Total Participants: 537
Treatment Group(s): 3
Primary Treatment: Drug: Semaglutide Administered SC
Phase: 3
Study Start date:
November 29, 2024
Estimated Completion Date:
November 14, 2026

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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