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
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
Treatments tested in this trial
- BGM0504
- semaglutide
Treatment groups
372 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov