320
Participants
Start Date
April 18, 2023
Primary Completion Date
November 21, 2023
Study Completion Date
March 15, 2024
EMP16-120/40
"EMP16 is supplied as oral MR capsules with the strength of 60 mg orlistat/20 mg acarbose.~Dosage:~week 1-2: 60 mg orlistat/20 mg acarbose (1 capsule per day), week 3-4: 60 mg orlistat/20 mg acarbose (1 capsule TID), week 5-26: 60 mg orlistat/20 mg acarbose (2 capsules TID)."
MR orlistat 120 mg
"MR orlistat 120 mg is the same as EMP16-120/40 but without the acarbose component in matching oral capsules.~Dosage:. week 1-2: 60 mg MR orlistat (1 capsule per day), week 3-4: 60 mg MR orlistat (1 capsule TID), week 5-26: 60 mg MR orlistat (2 capsules TID)."
Conventional orlistat 120 mg,
"Orlistat in its conventional form will be Alli® 60 mg during week 1 to 4 and Xenical® 120 mg from week 5 and onwards in matching oral capsules.~Dosage:~week 1-2: 60 mg conventional orlistat (1 capsule per day), week 3-4: 60 mg conventional orlistat (1 capsule TID), week 5-26: 120 mg conventional orlistat plus placebo (1 capsule of each TID)."
EMP16-60/20
"Dosage:~week 1-2: 60 mg orlistat/20 mg acarbose (1 capsule per day), week 3-4: 60 mg orlistat/20 mg acarbose (1 capsule TID), week 5-26: 60 mg orlistat/20 mg acarbose plus placebo (1 capsule of each TID)"
Placebo
"Dosage:~week 1-2: Placebo (1 capsule per day), week 3-4: Placebo (1 capsule TID), week 5-26: Placebo (2 capsules TID)"
CTC Ebbepark, Linköping
CTC Karolinska, Solna
Clinical Trial Consultants (CTC), Uppsala
Lead Sponsor
Collaborators (1)
CTC Clinical Trial Consultants AB
INDUSTRY
Empros Pharma AB
INDUSTRY