A Study of BGM0504 in Early T2DM With Obesity

NCT07743983 | Recruiting Phase 3 FDA Drug

• 1 other identifier: BGM0504-Ⅲ -T2DM-03
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.

Conditions

Type 2 Diabetes (T2DM)

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline

  Composite endpoint assessing both glycemic control and weight loss.

  Week 52

Secondary Outcomes (16)

• Proportion of Participants Achieving Diabetes Remission

  Week 64 (12 weeks off treatment)

• Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥10% from Baseline

  Weeks 12, 24, 36, 44

• Proportion of Participants Achieving HbA1c < 7.0% with Weight Reduction ≥ 5%, or 15% from Baseline

  Weeks 12, 24, 36, 44, 52

• Proportion of Participants Achieving HbA1c Targets (< 7.0%, ≤ 6.5%, < 5.7%)

  Weeks 12, 24, 36, 44, 52

• Proportion of Participants Achieving HbA1c ≤ 6.5% or < 5.7% with Weight Reduction ≥ 5%, 10%, or 15% from Baseline

  Weeks 12, 24, 36, 44, 52

Study Arms (2)

BGM0504 Injection 15 mg

EXPERIMENTAL

Drug: BGM0504

Semaglutide Injection 1.0 mg

ACTIVE COMPARATOR

Drug: semaglutide

Interventions

BGM0504 DRUG

Administered as a subcutaneous injection once weekly for 52 weeks.

BGM0504 Injection 15 mg

semaglutide DRUG

Administered as a subcutaneous injection once weekly for 52 weeks.

Semaglutide Injection 1.0 mg

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)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening.
• BMI 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening.
• Have HbA1c between ≥7.5% and ≤10.5% at screening.
• FPG ≤15.0 mmol/L at screening.
• If hypertensive: SBP \<180 mmHg and DBP \<110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks.
• Willing to comply with protocol, use effective contraception, and provide informed consent.

You may not qualify if:

• ● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.
• Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months.
• History of acute/chronic pancreatitis.
• Medullary thyroid carcinoma, MEN 2A/2B, or family history.
• Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence).
• Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias.
• Hemorrhagic or ischemic stroke within 6 months.
• Severe renal disease or eGFR ≤60 mL/min/1.73 m² (CKD-EPI).
• Pregnant or lactating woman.
• Prior clinical trial participation with investigational drug or device within 3 months.
• Other situations that are deemed as inappropriate for participation by investigators.

Sponsors & Collaborators

• BrightGene Bio-Medical Technology Co., Ltd.: lead

Study Sites (1)

Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School）

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Zhu

CONTACT

+86025-68182432; zhudalong@nju.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: July 24, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Locations

CN (1)