A Study of BGM0504 in Participants with Type 2 Diabetes

NCT06716216 | Recruiting Phase 3 FDA Drug

• 1 other identifier: BGM0504-Ⅲ -T2DM-02
• Study Type: interventional
• Target: 537
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes Mellitus (T2DM)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  Change from baseline in HbA1c after 32 weeks of treatment.

  Week 0 to Week 32

Secondary Outcomes (5)

• Change From Baseline in Body Weight

  Week 0 to Week 52

• Change From Baseline in Hemoglobin A1c (HbA1c)

  Week 0 to Week 52

• Percentage of Participants With HbA1c Target Value of <7%

  Week 0 to Week 52

• Percentage of Participants With HbA1c Target Value of <5.7%

  Week 0 to Week 52

• Change From Baseline in Fasting Serum Glucose

  Week 0 to Week 52

Study Arms (3)

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

EXPERIMENTAL

Drug: BGM0504 Administered SC

Drug: Drug: 5 mg BGM0504 Administered SC

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

EXPERIMENTAL

Drug: BGM0504 Administered SC

Drug: Drug:10 mg BGM0504 Administered SC

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

ACTIVE COMPARATOR

Drug: Semaglutide Administered SC

Drug: Drug: Semaglutide Administered SC

Interventions

Drug: 5 mg BGM0504 Administered SC DRUG

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

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.

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ■ 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%；

You may not qualify if:

• ■ 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.

Sponsors & Collaborators

• BrightGene Bio-Medical Technology Co., Ltd.: lead
• BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Linong Ji,MD, chief physician, Peking University People's Hospital

CONTACT

+86 13910978815; jiln@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: November 29, 2024
• Primary Completion: March 20, 2026
• Study Completion (Estimated): November 14, 2026
• Last Updated: February 7, 2025

Record last verified: 2024-10

Locations

CN (1)