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

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.

Start Date18 Apr 2023

Sponsor / Collaborator

Empros Pharma AB

[+1]

NCT04521751 / CompletedPhase 1/2

Lean Efficacy Phase IIa Proof of Concept Trial (LEAAP). A Study in Overweight and Obese Patients During Twenty-six Weeks, Investigating the Effect of EMP16-02 on Body Weight, Safety and Clinical Biomarkers

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.

Start Date07 May 2020

Sponsor / Collaborator

Empros Pharma AB

[+1]

100 Clinical Results associated with LIPF x MGAM

100 Translational Medicine associated with LIPF x MGAM

0 Patents (Medical) associated with LIPF x MGAM

Literatures (Medical) associated with LIPF x MGAM

01 Aug 1986·Monatsschrift Kinderheilkunde : Organ der Deutschen Gesellschaft fur KinderheilkundeQ4 · MEDICINE

[Nutrition of premature infants below 1,500 g: enteral prerequisites].

Q4 · MEDICINE

Article

Author: Lentze, M J

The development of the human fetal gastrointestinal tract takes place early during gestation. The pancreas although developed by morphological means at the 16th week of gestation excretes its exocrine enzymes later at the 24th week of gestation except for amylase which reaches its full activity 6 months after birth. Trypsinogen secreted at the 24th week is activated into trypsin by enterokinase at the 26th week of gestation whereas lipase and colipase are secreted from the 24th week. The small intestine starts developing at the 10th week morphologically and functionally. At the same time when villi and crypts start to develop at the 11th to 12th week the first enzyme activities can be detected, i.e. sucrase-isomaltase, maltase-glucoamylase and lactase. Also peptidases and lysosomal hydrolases are measured at this age. With the exception of lactase, intestinal enzymes reach sufficient activities at the 25th week of gestation. Lactase activity remains low until the 32nd-34th week. For the digestion and absorption of lipids, protein and carbohydrates the gastrointestinal tract of premature infants under 1500 g in rather well equipped. Lipids are hydrolysed by the mutual action of breast milk lipase, lingual lipase, gastric lipase and pancreatic lipase. The carbohydrates lactose and oligosaccharides as supplements to breast milk are hydrolysed by lactase, sucrase-isomaltase and maltase-glucoamylase. Breast milk proteins and cows milk hydrolysates are digested by pancreatic proteases into oligopeptides which can be hydrolysed within the lumen by brush border peptidases and be absorbed. Peptides also can actively be transported through the microvillus membrane and be hydrolyzed by intracellular peptidases.(ABSTRACT TRUNCATED AT 250 WORDS)

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