A Study of BGM0504 in Participants with Type 2 Diabetes

Phase 3

Recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06716216
• Lead Sponsor: BrightGene Bio-Medical Technology Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-29
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Submitted: 2025-02-06
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-03-20
• Study Completion: 2026-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 537

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Hemoglobin A1c (HbA1c)	Week 0 to Week 32	Change from baseline in HbA1c after 32 weeks of treatment.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Week 0 to Week 52	Change from baseline in body weight after 52 weeks of treatment.
Change From Baseline in Hemoglobin A1c (HbA1c)	Week 0 to Week 52	Change from baseline in HbA1c after 52weeks of treatment.
Percentage of Participants With HbA1c Target Value of <7%	Week 0 to Week 52	Percentage of Participants With HbA1c Target Value of \<7% after 52weeks of treatment.
Percentage of Participants With HbA1c Target Value of <5.7%	Week 0 to Week 52	Percentage of Participants With HbA1c Target Value of \<5.7%after 52weeks of treatment.
Change From Baseline in Fasting Serum Glucose	Week 0 to Week 52	Change from baseline in FPG after 52 weeks of treatment.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China