NCT05934110

Study Exploring the Supportive Effect of Acarbose in Weight Management

A 26-week, Double-blind, Randomized Study in Participants With Overweight or Obesity Investigating the Added Contribution of Acarbose in EMP16 on Efficacy, Safety and Tolerability

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Empros Pharma AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	EMP16-120/40	EMP16 is supplied as oral MR capsules with the strength of 60 mg orlistat/20 mg acarbose. Dosage: week 1-2: 60 mg orlistat/20 mg acarbose (1 capsule per day), week 3-4: 60 mg orlistat/20 mg acarbose (1 capsule TID), week 5-26: 60 mg orlistat/20 mg acarbose (2 capsules TID).
DRUG	MR orlistat 120 mg	MR orlistat 120 mg is the same as EMP16-120/40 but without the acarbose component in matching oral capsules. Dosage:. week 1-2: 60 mg MR orlistat (1 capsule per day), week 3-4: 60 mg MR orlistat (1 capsule TID), week 5-26: 60 mg MR orlistat (2 capsules TID).
DRUG	Conventional orlistat 120 mg,	Orlistat in its conventional form will be Alli® 60 mg during week 1 to 4 and Xenical® 120 mg from week 5 and onwards in matching oral capsules. Dosage: week 1-2: 60 mg conventional orlistat (1 capsule per day), week 3-4: 60 mg conventional orlistat (1 capsule TID), week 5-26: 120 mg conventional orlistat plus placebo (1 capsule of each TID).
DRUG	EMP16-60/20	Dosage: week 1-2: 60 mg orlistat/20 mg acarbose (1 capsule per day), week 3-4: 60 mg orlistat/20 mg acarbose (1 capsule TID), week 5-26: 60 mg orlistat/20 mg acarbose plus placebo (1 capsule of each TID)
DRUG	Placebo	Dosage: week 1-2: Placebo (1 capsule per day), week 3-4: Placebo (1 capsule TID), week 5-26: Placebo (2 capsules TID)

Timeline

• Start date: 2023-04-18
• Primary completion: 2023-11-21
• Completion: 2024-03-15
• First posted: 2023-07-06
• Last updated: 2024-02-20

Locations

3 sites across 1 country: Sweden