acarbose/orlistat (EMP16) / Empros Pharma - LARVOL DELTA

A Comparative Analysis of the Pharmacodynamic and Pharmacokinetic Properties of 2 Controlled-Release Formulations Versus a Marketed Orlistat Product. (PubMed, Clin Pharmacol Drug Dev) - "This shows that the new weight loss product MR-OA retains the dietary energy loss pathway used in Conv-O. Consistent with previous studies, minimal systemic absorption of orlistat and acarbose was observed for MR-OA, confirming that no significant alteration of the original substances occurs when modifying their release."

Journal • PK/PD data • Genetic Disorders

Study Exploring the Supportive Effect of Acarbose in Weight Management (clinicaltrials.gov) - P2 | N=320 | Active, not recruiting | Sponsor: Empros Pharma AB | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Mar 2024

Enrollment closed • Trial completion date • Genetic Disorders • Obesity

A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Empros Pharma AB | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

A Phase 1 Study to Evaluate EMP22 PD and EMP16 PK Versus Xenical® in Healthy Volunteers (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Empros Pharma AB

New P1 trial • Genetic Disorders • Obesity

Study Exploring the Supportive Effect of Acarbose in Weight Management (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Empros Pharma AB

New P2 trial • Genetic Disorders • Obesity • APOA1 • APOB

Effects of a novel weight-loss combination product containing orlistat and acarbose on obesity: A randomized, placebo-controlled trial. (PubMed, Obesity (Silver Spring)) - "This trial indicates that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues. EMP16 may be a promising candidate among other medications for improved weight management."

Clinical • Journal • Genetic Disorders • Obesity

A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary) (clinicaltrials.gov) - P2a | N=156 | Completed | Sponsor: Empros Pharma AB | Active, not recruiting ➔ Completed

Biomarker • Trial completion • Genetic Disorders • Obesity • CRP

A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary) (clinicaltrials.gov) - P2a; N=156; Active, not recruiting; Sponsor: Empros Pharma AB; Recruiting ➔ Active, not recruiting; Trial completion date: Apr 2021 ➔ Aug 2021; Trial primary completion date: Apr 2021 ➔ Aug 2021

Biomarker • Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity • CRP

A Proof of Concept Trial in Overweight and Obese Patients, Investigating Effect of EMP16-02 on Body Weight (Primary) (clinicaltrials.gov) - P2a; N=156; Recruiting; Sponsor: Empros Pharma AB

Biomarker • Clinical • New P2a trial • Genetic Disorders • Obesity