A Trial With EMP16 in Preparation for Late Phase Studies

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

May 20, 2025

Primary Completion Date

July 29, 2025

Study Completion Date

July 29, 2025

Conditions
Overweight or ObeseObesity and Overweight
Interventions
DRUG

EMP16-02 120 mg orlistat/40 mg acarbose

Days 1 to 14: 1 capsule/day, Day 15 to 28, 1 capsule TID and Days 29 to 39: 2 capsules TID).Target dose EMP16: 120 mg orlistat/40 mg acarbose.

DRUG

Alli® 60 mg

Days 1 to 14: 1 capsule/day, Day 15 to 28, 1 capsule TID and Days 29 to 39: 2 capsules TID).Target dose EMP16: 120 mg orlistat/40 mg acarbose.

DIETARY_SUPPLEMENT

Vi-Siblin® S

Vi-Siblin® S will be taken according to a dose-escalation schedule, with 20 ml (corresponding to approximately 8 g) in the morning during Days 1 to 14; then 20 ml in the morning and evening the rest of the trial (total daily dose 16 g).

DIETARY_SUPPLEMENT

Maltodextrin

Maltodextrin will be taken according to a dose-escalation schedule, with 20 ml (corresponding to approximately 8 g) in the morning during Days 1 to 14; then 20 ml in the morning and evening the rest of the trial (total daily dose 16 g).

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Empros Pharma AB

INDUSTRY