Clinical Research
- Home
- Clinical Program
Aim
The aim was to investigate the safety and tolerability of EMP16 in doses 60/20, 90/30, and 120/40 and Xenical as a comparator. The effect was measured as an appetite questionnaire, gastrointestinal symptom score, body weight, meal pattern, and several different biomarkers.
Design
A randomized, controlled, open trial during 14 days on adult men with obesity. In total 67 men were included in the trial and divided into 4 treatment arms. EMP16 was administered three times per day together with the main meals. Day 1 and day 14 in the trial were full days at the clinic with a controlled diet and sampling. LINK TO CLINICAL PROTOCOL
Results
This study showed that EMP16 has better glycemic control and less side effects such as oily stools and fecal incontinence, than Xenical. The hunger ratings were reduced more during 14 days for the EMP16 120/40 treatment group compared with the Xenical group. The plasma exposure of orlistat was lower for EMP16, which indicates improved safety. Together EMP16 has the clinical potential to be a safe and effective treatment of obese subjects with and without reduced glucose control.
LINKS
Aim
To evaluate the effect of EMP16 on relative body weight after 26 weeks compared with placebo.
Design
A 26-week double-blind, placebo-controlled trial, where 156 participants were randomized into three arms: EMP16 120-mg orlistat/40-mg acarbose (EMP16-120/40), EMP16-150/50, or placebo.
Results
The placebo-corrected weight loss was 4.70% with EMP16-120/40 and 5.42% with EMP16-150/50. This trial shows that orlistat and acarbose can be successfully combined in a modified-release formulation to provide efficacious weight loss with no unexpected safety issues.
LINKS
To confirm the added effect of acarbose in EMP16-120/40 on efficacy after a 26-week period of oral treatment compared with modified release orlistat (MR O) and conventional orlistat.
DesignThis was a 26-week long, double-blind study in participants with overweight or obesity where 320 women and men were randomized to: EMP16-120/40, EMP16-60/20, MR O 120 mg, conventional orlistat 120 mg or placebo.
Key outcome variables were relative weight loss, categorical weight loss, anthropometry, glucose and lipid metabolism markers as well as safety and tolerability.
Results
[Data will be presented soon]
Part 1: To confirm the pharmacodynamic equivalence of the modified release (MR) orlistat component of the study drug EMP16 to conventional orlistat.
Part 2: To explore the pharmacokinetics of both orlistat and acarbose using the study drug EMP16.
DesignPart 1: This was a randomized, single-blind, crossover study in 20 healthy volunteers, where diet was provided. After a five-day diet run-in period, participants took MR orlistat (120 mg orlistat) and orlistat in its conventional form (120 mg orlistat) 3 times daily (TID) together with the 3 main daily meals during two nine-days periods. At the end of the run-in and at the end of each nine-day period, the volunteers delivered a stool sample for measurement of fecal fat percentage.
Part 2: The participants had two whole-day visits to the clinical research center. In the first visit, the subjects took one dose of EMP16 120 mg orlistat / 40 mg and blood was collected for 12 h, for analyses of orlistat and acarbose. On the second visit, the subjects took one dose of conventional orlistat (120 mg orlistat) and blood was collected for 12 h, for analysis of orlistat.
ResultsPart 1: Pharmacodynamic equivalence was concluded as the fecal fat percentages were not different between modified release orlistat and conventional orlistat.
Part 2: The safety of EMP16 was confirmed as low plasma concentrations (mean concentration <5 ng / ml) were observed for both orlistat and acarbose.
To assess the safety and efficacy of EMP16 during a 56-week period of oral treatment as compared with placebo in subjects with type 2 diabetes and overweight or obesity
Tentative design
This is a multicenter, randomized, double-blind, placebo-controlled, phase III study in about 300 subjects with type 2 diabetes and overweight or obesity, who will be randomized in a 2:1 ratio to EMP16 or placebo. Co-primary endpoints will be changed from week 0 to week 52 in body weight (%) as compared to placebo and the proportion of subjects who after 52 weeks achieve a body weight reduction ≥ 5% from week 0 as compared to placebo. Important secondary endpoints are anthropometry, glucose, and lipid metabolism markers as well as safety and tolerability.
Results[Data will be presented in the beginning of 2026]
To assess the safety and efficacy of EMP16 during a 56-week period of oral treatment as compared with placebo in in subjects with overweight or obesity.
Tentative design
This is a multicenter, randomized, double-blind, placebo-controlled, phase III study in about 220 subjects with overweight or obesity, who will be randomized in a 2:1 ratio to EMP16 or placebo.Co-primary endpoints will be changed from week 0 to week 52 in body weight (%) as compared to placebo and the proportion of subjects who after 52 weeks achieve a body weight reduction ≥ 5% from week 0 as compared to placebo Important secondary endpoints are anthropometry, glucose, and lipid metabolism markers as well as safety and tolerability.
Results
[Data will be presented in the beginning of 2026]