Study Exploring the Supportive Effect of Acarbose in Weight Management

Status Active, not recruiting

Clinical Trial Summary

This is a randomized, double-blind study in participants with overweight or obesity in which the effect of acarbose and the impact of dose on efficacy, safety and tolerability is investigated by comparing the EMP16 combination product with modified release (MR) orlistat, orlistat in its conventional dosage form and placebo.

Clinical Trial Description

The study will be conducted at 3 research sites in Sweden. A total of 320 randomized patients are expected to participate in the study for approximately 31 weeks, including a screening period of up to 5 weeks and a 26-weeks treatment period. EMP16 is indicated for people with obesity with an initial BMI ≥ 30 kg/m² or ≥ 27 kg/m² in the presence of other risk factors (e.g., hypertension, glucose dysregulation and T2DM, and/or dyslipidemia). Participants will be randomized to either of 5 arms: - EMP16-120/40, 80 participants - MR orlistat 120 mg, 80 participants - Conventional orlistat 120 mg, 80 participants - EMP16-60/20, 40 participants - Placebo, 40 participants ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05934110
Study type	Interventional
Source	Empros Pharma AB
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	April 18, 2023
Completion date	March 15, 2024

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