A Clinical Study to Investigate if SAR425899 Binds to the Liver and Pancreas in Overweight to Obese Type 2 Diabetes Mellitus Patients

What Was Tested

The trial (phase 1) is built around Exenatide.

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Study duration is approximately 7 weeks with a 20 days treatment period.

Who Took Part

Enrollment: 13 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male and female patients, between 18 and 75 years of age, inclusive. Body weight between 60.0 and 120.0 kg, inclusive, body mass index between 28.0 and 38.0 kg/m2, inclusive.

The full record lists 5 inclusion and 17 exclusion criteria; among the exclusions: surgically treated obesity, bariatric surgery; severe hypoglycemia resulting in seizure/unconsciousness/coma or hospitalization for diabetic ketoacidosis in the last 3 months before screening; persistent hyperglycemia not adequately controlled by metformin, sus and/or diet/exercise.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Exenatide study did not mask who received what.

It started in 2017-12-20 with completion listed for 2018-06-07.

It ran at 1 site in Sweden.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Glucagon receptor occupancy (time frame: Day 1 and Day 20).

It also tracked 15 secondary outcomes, for example GLP-1 receptor occupancy, Adverse events, Change in fasting plasma glucose (FPG), Change in ketone bodies, Change lipid biomarkers and Change in volume of distribution (Vt) in the liver.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Exenatide in 13 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.