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

NCT06716203 | Recruiting Phase 3 FDA Drug

• 1 other identifier: BGM0504-Ⅲ -T2DM-01
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

EXPERIMENTAL

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

Drug: Drug: 5 mg BGM0504 Administered SC

Experimental: 10 mg BGM0504

EXPERIMENTAL

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

Drug: Drug: : 10 mg BGM0504 Administered SC

Placebo Comparator: Placebo

PLACEBO COMPARATOR

Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.

Drug: Drug: Placebo Administered SC

Interventions

Drug: 5 mg BGM0504 Administered SC DRUG

Drug: BGM0504 Administered SC

Experimental: 5 mg BGM0504

Drug: : 10 mg BGM0504 Administered SC DRUG

Drug: BGM0504 Administered SC

Experimental: 10 mg BGM0504

Drug: Placebo Administered SC DRUG

Drug: Placebo Administered SC

Placebo Comparator: Placebo

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);
• 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.

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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: December 2, 2024
• Primary Completion: December 29, 2025
• Study Completion (Estimated): August 25, 2026
• Last Updated: February 7, 2025

Record last verified: 2024-10

Locations

CN (1)