This study is open to adults with overweight or obesity who also have fatty liver disease. The purpose of this study is to find the highest dose of BI 3006337 that people with overweight or obesity and with fatty liver disease can tolerate. Participants are divided into 4 groups of equal size randomly, which means by chance. Different doses of BI 3006337 are given to participants in each group. Participants in each group receive an injection of either BI 3006337 or placebo once a week. Placebo injections look like BI 3006337 injections but do not contain any medicine. Participants are in the study for about 4 months. During this time, they visit the study site 18 times. Three of the visits include overnight stays at the study site. The doctors check the health of the participants and note any health problems that could have been caused by BI 3006337.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Subject with overweight/obesity and steatosis received subcutaneous solution once weekly.
Subject with overweight/obesity and steatosis received subcutaneous solution once weekly.
Velocity Clinical Research-Chula Vista
Chula Vista, California, United States
Velocity Clinical Research-La Mesa-69117
La Mesa, California, United States
Catalina Research Institute, LLC-Montclair-49051
Montclair, California, United States
Accel Research Sites-Deland-67606
DeLand, Florida, United States
Floridian Clinical Research-Miami Lakes-68368
Miami Lakes, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
Centricity Research-Columbus-68879
Columbus, Ohio, United States
AMR Knoxville
Knoxville, Tennessee, United States
The Liver Institute at Methodist Dallas
Dallas, Texas, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
...and 2 more locations
Number of Subjects With Drug-related Adverse Events (AEs)
Number of subjects with drug-related adverse events (AEs) occurring between first administration of trial medication (BI 3006337 or placebo) and end of study (EOS) is reported.
Time frame: From drug administration of BI 3006337 until end of the treatment, up to 99 days
Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Dosing Interval Tau at Steady State (AUCτ,ss) After the Last Dose in Week 12
Area under the concentration-time curve of BI 3006337 in serum over the dosing interval tau at steady state (AUCτ,ss) after the last dose in Week 12 is reported.
Time frame: 0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 and 504 hours after drug administration in week 12
Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Cmax,ss) After the Last Dose in Week 12
Maximum measured concentration of BI 3006337 in serum at steady state (Cmax,ss) after the last dose in Week 12 is reported.
Time frame: 0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 hours after drug administration in week 12
Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Tmax,ss) After the Last Dose in Week 12
Time from dosing to the maximum measured concentration of BI 3006337 in serum at steady state (tmax,ss) after the last dose in Week 12 is reported.
Time frame: 0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 hours after drug administration in week 12
Relative Percentage Change in Liver Steatosis From Baseline After 12 Weeks of Treatment
Relative percentage change in liver steatosis from baseline after 12 weeks of treatment is reported. Liver steatosis is measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Baseline (-48 to -4): the last observed measurement prior to drug administration, Day 85
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.