Overview

A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary)

Status:
Active, not recruiting

Trial end date:
2021-08-30

Target enrollment:

Participant gender:

Summary

This study is a proof of concept study to demonstrate that EMP16-02, a fixed dose combination (FDC) of orlistat and acarbose in an oral multiple-unit modified release (MR) formulation leads to a clinically relevant decrease in body weight. The study aims to evaluate the efficacy, safety and tolerability of treatment with two different doses of EMP16 02 (120 mg orlistat/40 mg acarbose and 150 mg orlistat/50 mg acarbose) for 26 weeks on reducing body weight in obese patients.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

Empros Pharma AB

Collaborators:

Clinical Trial Consultants AB
CTC Clinical Trial Consultants AB

Treatments:

Acarbose
Orlistat