The purpose of this clinical study is to find out if NNC4005-0001 is well-tolerated and safe for people who have increased body weight and increased liver fat. Participants will receive either NNC4005-0001, which is the treatment being tested, or a placebo, which is a treatment that contains no active medicine. The study will last for about for about 7 to 8 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
NNC4005-0001 will be given as a single ascending dose via subcutaneous route
Placebo matched to NNC4005-0001 will be given via subcutaneous route
Altasciences Clinical Company, Inc
Montreal, Quebec, Canada
RECRUITINGNumber of Treatment-emergent adverse event (TEAEs)
Measured as count of events
Time frame: From dosing (day 1) until compeletion of end of study (EOS) visit on day 169
AUC(0-last): The area under the NNC4005-0001 plasma concentration-time curve from time zero to last measurable concentration after a single dose
microgram\*hour per milliliter (μg\*h/mL)
Time frame: From dosing (day 1) to 48 hours post-dose
Cmax: The maximum concentration of NNC4005-0001 in plasma
Measured in microgram per millilitre
Time frame: From dosing (day 1) to 48 hours post-dose
tmax: The time from dose administration to the maximum plasma concentration of NNC4005-0001
Hour
Time frame: From dosing (day 1) to 48 hours post-dose
t1/2: Half life
Hour
Time frame: From dosing (day 1) to 48 hours post-dose
CLr: Renal clearance
Liter/hour (L/h)
Time frame: From dosing (day 1) to 48 hours post-dose
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