This study will look at how well a new medicine called NNC0519-0130 helps people with type 2 diabetes lower their blood sugar and body weight. The study will test up to 7 different doses of NNC0519-0130. Which treatment participant will get is decided by chance. Participants will take 1-3 injections once a week. The study medicine will be injected under skin with a thin needle in the stomach, thigh, or upper arm. The study will last for about 40 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
299
NNC0519-0130 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Trizepatide will be administered subcutaneously.
Change in Glycated haemoglobin (HbA1c)
Measured as percentage point (%-point)
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose
Change in Glycated haemoglobin (HbA1c)
Measured as percentage point (%-point)
Time frame: From baseline (week 0) to end of treatment (week 36)
Relative change in body weight
Measured as percentage (%)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in body weight
Measured as kilograms (kg)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in fasting plasma glucose (FPG)
Measured as millimoles per liter (mmol/L)
Time frame: From baseline (week 0) to 12 weeks on a given maintenance dose
Continuous glucose monitoring (CGM): Change in time in range (TIR) 3.9-10.0 millimoles per liter (mmol/L) (70-180 milligrams per deciliter (mg/dL))
Measured as percentage point (%-point)
Time frame: From baseline (week -2 to week 0) to week 22-24 and week 34-36, respectively
Change in waist circumference
Measured as centimeter (cm)
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in systolic blood pressure (SBP)
Measured as millimeters of mercury (mmHg)
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Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high sensitivity C-Reactive Protein (hsCRP)
Measured as ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in total cholesterol
Measured as ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in high-density lipoprotein (HDL) cholesterol
Measured as ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in low-density lipoprotein (LDL) cholesterol
Measured as ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Change in triglycerides
Measured as ratio to baseline
Time frame: From baseline (week 0) to end of treatment (week 36)
Number of adverse events
Measured as number of events
Time frame: From baseline (week 0) to end of study (week 40)