Study Exploring the Supportive Effect of Acarbose in Weight Management

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

April 18, 2023

Primary Completion Date

November 21, 2023

Study Completion Date

March 15, 2024

Conditions
Overweight or Obesity
Interventions
DRUG

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)."

DRUG

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)."

DRUG

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)."

DRUG

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)"

DRUG

Placebo

"Dosage:~week 1-2: Placebo (1 capsule per day), week 3-4: Placebo (1 capsule TID), week 5-26: Placebo (2 capsules TID)"

Trial Locations (3)

SE-582 13

CTC Ebbepark, Linköping

SE-171 64

CTC Karolinska, Solna

SE-752 37

Clinical Trial Consultants (CTC), Uppsala

Sponsors
All Listed Sponsors
collaborator

CTC Clinical Trial Consultants AB

INDUSTRY

lead

Empros Pharma AB

INDUSTRY