The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
NCT Number: NCT07836140
An Investigator-Initiated, Randomized, Open-Label, Active-Controlled Study Comparing the Effects of BGM0504 Injection versus Semaglutide Injection on Insulin Sensitivity and Body Weight in Obese Subjects
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Suzhou, Jiangsu, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multiple ascending doses of semaglutide administered SC
Multiple ascending doses of BGM0504 administered SC
Time frame: Target dose at week 16
Change in the HOMA2-β (steady-state model for beta-cell function assessment) index from baseline at Week 16 of the target dosage
Time frame: Target dose at week 16
Change in the HOMA2-IR (homeostasis model assessment of insulin resistance) index from baseline at Week 16 of the target dose
Time frame: Target dose at week 16
Target dose: relative percentage change in skeletal muscle fat infiltration (MFI) from baseline at Week 16
Time frame: Target dose at week 16
Change from baseline in fasting insulin levels at week 16 following administration of the target dose
Time frame: Target dose at week 16
Change from baseline in fasting blood glucose at week 16 of the target dose administration
Time frame: Target dose at week 16
Change in fasting C-peptide from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
change in fasting glucagon from baseline at Week 16 after administration of the target dose
Time frame: At 30 minutes, 60 minutes, and 120 minutes compared to the baseline.
Changes in blood glucose, insulin, C-peptide, and glucagon at 30 minutes, 60 minutes, and 120 minutes after oral glucose administration compared to baseline
Time frame: Target dose at week 16
The relative percentage change in fasting weight from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Change in serum uric acid from baseline at Week 16 of target-dose administration
Time frame: Target dose at week 16
Change in triglycerides from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Change in cholesterol from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Change in low-density lipoprotein from baseline at Week 16 of targeted dosing
Time frame: Target dose at week 16
Change in high-density lipoprotein from baseline at Week 16 after targeted dosing
Time frame: Target dose at week 16
Change in free fatty acids from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
Changes in ACTH and cortisol from baseline at Week 16 of targeted dosing
Time frame: Target dose at week 16
Change in fat-free muscle volume from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
The relative percentage change in visceral fat from baseline at Week 16 after administration of the target dose
Time frame: Target dose at week 16
The relative percentage change from baseline in subcutaneous fat at Week 16 following administration of the target dose
Time frame: Target dose at week 16
The relative percentage change in liver fat from baseline at Week 16 after administration of the target dose
Second Affiliated Hospital of Soochow University
Other
An Investigator-Initiated, Randomized, Open-Label, Active-Controlled Study Comparing the Effects of BGM0504 Injection Versus Semaglutide Injection on Insulin Sensitivity and Body Weight in Obese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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