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

Effect of dietary counseling and dietary fiber on tolerability during weight management with EMP16 and conventional orlistat: a single-blind randomized pilot trial. (PubMed, Sci Rep) - "Greater relative weight loss occurred with EMP16 plus fiber vs. conventional orlistat plus placebo (p = 0.026), with similar ~ 10% LDL-cholesterol reductions. Dietary counseling during treatment with EMP16 or conventional orlistat may mitigate GI side effects in adults with prior GI side effects and co‑administration of fiber might further enhance tolerability and efficacy."

Journal • Genetic Disorders • Obesity

The Supportive Effect of Acarbose to Orlistat in Weight Management-A Randomized, Double-Blind, Multiarm Phase 2 Trial. (PubMed, Obesity (Silver Spring)) - P2 | "Acarbose enhances the weight loss efficacy of EMP16, supporting its potential as a safe and effective treatment for long-term obesity management."

Clinical • Journal • P2 data • Genetic Disorders • Obesity

POEM: A Trial With EMP16 in Preparation for Late Phase Studies (clinicaltrials.gov) - P2 | N=39 | Not yet recruiting | Sponsor: Empros Pharma AB

New P2 trial • Genetic Disorders • Obesity

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