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Active, not recruiting Phase 3

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

NCT06716203 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-01-03
Last updated
2026-10-15

Condition(s) studied

Type 2 Diabetes Mellitus (T2DM)

Investigational drug(s) / intervention(s)

Drug: 5 mg BGM0504 Administered SC →Drug: : 10 mg BGM0504 Administered SC →Drug: Placebo Administered SC

Drug: 5 mg BGM0504 Administered SC: Drug: BGM0504 Administered SC

Drug: : 10 mg BGM0504 Administered SC: Drug: BGM0504 Administered SC

Drug: Placebo Administered SC: Drug: Placebo Administered SC

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Beijing Municipality
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06716203 on ClinicalTrials.gov ↗ ← All trials in China