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

NCT04521751 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2022-04-04

No results posted yet for this study

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.

Conditions

  • Overweight or Obesity

Interventions

DRUG

EMP16-02 120 mg orlistat/40 mg acarbose

EMP16-02 capsules are composed of three pharmaceutical fractions (granules denoted G1, G2 and G3). G1= Prolonged release of acarbose, G2= Enteric-coated granule fraction containing orlistat and acarbose, G3= Orlistat with a delayed on-set release mechanism.

DRUG

EMP16-02 150 mg orlistat/50 mg acarbose

EMP16-02 capsules are composed of three pharmaceutical fractions (granules denoted G1, G2 and G3). G1= Prolonged release of acarbose, G2= Enteric-coated granule fraction containing orlistat and acarbose, G3= Orlistat with a delayed on-set release mechanism.

DRUG

Placebo

Matching oral placebo capsules

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • Empros Pharma AB

    lead INDUSTRY

Principal Investigators

  • Helena Litorp, MD, PhD · CTC Clinical Trial Consultants AB

  • Daniel Wilhelms, MD, PhD · CTC Clinical Trial Consultants AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-07
Primary Completion
2021-08-30
Completion
2021-08-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04521751 on ClinicalTrials.gov