A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.

The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Drug: Drug: 5 mg BGM0504 Administered SC; Drug: Drug: : 10 mg BGM0504 Administered SC; Drug: Drug: Placebo Administered SC

• Study Type: Interventional
• Enrollment (Estimated): 207
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Linong Ji,MD, chief physician, Peking University People's Hospital; Phone Number: +86 13910978815; Email: jiln@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Linong Ji; Phone Number: +860139010978815; Email: jiln@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

  • 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%；
  • Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: 5 mg BGM0504; Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.	Drug: Drug: 5 mg BGM0504 Administered SC; Drug: BGM0504 Administered SC
Experimental: Experimental: 10 mg BGM0504; Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.	Drug: Drug: : 10 mg BGM0504 Administered SC; Drug: BGM0504 Administered SC
Placebo Comparator: Placebo Comparator: Placebo; Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.	Drug: Drug: Placebo Administered SC; Drug: Placebo Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c)	Change from baseline in HbA1c after 32 weeks of treatment.	Week 0 to Week 32

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BrightGene Bio-Medical Technology Co., Ltd.
• Collaborators: BrightGene New Bio-Medical Technology(Wuxi) Co.Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2024
• Primary Completion (Estimated): December 29, 2025
• Study Completion (Estimated): August 25, 2026

Study Registration Dates

• First Submitted: November 29, 2024
• First Submitted That Met QC Criteria: November 29, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: BGM0504-Ⅲ -T2DM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No