PERFORMS
Background
Adults who are overweight or living with obesity have an increased risk of health problems, such as type 2 diabetes and heart disease, and every day physical tasks can be harder to perform. We call this ‘impaired physical function’. Adults living with obesity can have similar physical function and strength levels to a person of healthy weight who is 10-20 years older. Having other problems, like diabetes, may make physical function worse.
There are many ways to measure physical function, including timed walking tests, balance tests, and tasks that require muscle activity (e.g., sitting and standing from a chair) repeated as many times as possible within a set time. One benefit of these tests is that they can be performed in everyday settings without expensive equipment (such as at a healthcare appointment), allowing GPs and other healthcare providers to use them.
Currently, we do not know which physical function tests work best in people who are overweight or living with obesity, who also have low muscle strength. We also do not know how having diabetes may impact physical function and strength in this population.
We want to measure lots of different physical function tests, to find out which tests:
Give us the best understanding of physical function, when compared to more expensive, complicated tests from a research centre;
Will give similar results if performed more than once in a short time period;
Can be performed safely by people who are overweight or living with obesity.
Study aims
This study is a phase 3 randomised, double blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of Maridebart Cafraglutide in adult participants with type 2 diabetes mellitus who have obesity or are overweight.
Participants will be in the study for a total of 88 weeks including:
An up to 28 day (4 week/1 month) screening period
A 72 week (about 1.5 years) treatment period
A 12 week (3 month) safety follow up period
Study summary
Study progress
The study is currently recruiting participants.
This research is funded by Regeneron Pharmaceuticals Inc., New York, USA. The research is being coordinated by researchers at the Leicester Biomedical Research Centre, based at the Leicester General Hospital.
Funding and sponsorship
Study publications
This section will be updated if any publications become available.
Chief Investigator: Professor Thomas Yates
Principal Investigator: Dr Thomas Wilkinson
For more information, please contact: PERFORMSstudy@leicester.ac.uk or call:0116 258 8973