Health TrialsbyHealthPanel

A Study of BGM0504 in Early T2DM With Obesity

ConditionType 2 Diabetes (T2DM)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBrightGene Bio-Medical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

○ 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.

Disqualifiers

● 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGM0504

    Drug

    Administered as a subcutaneous injection once weekly for 52 weeks.

  • semaglutide

    Drug

    Administered as a subcutaneous injection once weekly for 52 weeks.

Treatment groups

372 Participants
are divided into 2 treatment groups
Group A: BGM0504 Injection 15 mgExperimental treatment 1 intervention
Group B: Semaglutide Injection 1.0 mgActive comparator 1 intervention

Trial outcomes

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.

Time frame
Week 52

Secondary outcomes

1

Proportion of Participants Achieving Diabetes Remission

Defined as HbA1c \< 6.5% without use of glucose-lowering medications.

Time frame
Week 64 (12 weeks off treatment)
2

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

Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.

Time frame
Weeks 12, 24, 36, 44
3

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

Composite endpoint assessing combined glycemic and weight outcomes at multiple thresholds.

Time frame
Weeks 12, 24, 36, 44, 52
4

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

Glycemic control assessed at each visit.

Time frame
Weeks 12, 24, 36, 44, 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BrightGene Bio-Medical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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