Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619015
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
Tailoring Obesity Treatment Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Pramlintide on Top of Semaglutide in Obese People With Prediabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TOTT
Brief Summary:
The two main aims of this clinical study is
1 To investigate if the results from a series of physiological tests and questionnaires prior to treatment can be used to predict the treatment response to obesity medication
2 To investigate the effect of combining semaglutide and pramlintide on various aspects of appetite food preference and eating habits
The study is planed as a 26 week double blinded randomized placebo controlled trial The goal is to include N40 They will all receive weekly semaglutide injections After 24 weeks they will be randomized to receive either an amylin analog pramlintide or placebo as a continuous infusion for two weeks in addition to weekly semaglutide
The results from this study will contribute to identifying possible predictors of treatment response enabling optimal individualized medical weight loss treatment As well as providing knowledge on the complex interplay between incretin hormones and their effects on appetite and eating habits
1 To investigate if the results from a series of physiological tests and questionnaires prior to treatment can be used to predict the treatment response to obesity medication
2 To investigate the effect of combining semaglutide and pramlintide on various aspects of appetite food preference and eating habits
The study is planed as a 26 week double blinded randomized placebo controlled trial The goal is to include N40 They will all receive weekly semaglutide injections After 24 weeks they will be randomized to receive either an amylin analog pramlintide or placebo as a continuous infusion for two weeks in addition to weekly semaglutide
The results from this study will contribute to identifying possible predictors of treatment response enabling optimal individualized medical weight loss treatment As well as providing knowledge on the complex interplay between incretin hormones and their effects on appetite and eating habits
Detailed Description:
Obesity is a major global health challenge and the prevalence of obesity is increasing Presence of obesity increases the risk of several diseases physical limitations and an increased mortality When weightloss is wanted in order to avoid or treat some of these diseases medical weight loss treatment is one of the options Among these modified gut hormones such as Glucagon Like Peptide -1 Receptor agonists GLP-1RA However the individual response to GLP-1RA treatments varies considerably Currently the best predictor of total weight loss is achieved weight loss after three months of treatment With more pharmaceutical options to come a trial and error approach is not appropriate There is a need to identify possible pre-treatment predictors to treatment response
This is one of the project39s main aims By being able to predict the treatment response one can tailor the obesity treatment to the individual improving the treatment outcome
Amylin is co-secreted with insulin from the pancreas in response to meals It is found to have many similar effects in the body as GLP-1 However their combination especially on appetite food preferences and eating pattern is sparsely investigated This is the other main aim of the project
This clinical study will be a 26 week randomized double-blinded placebo-controlled trial Forty overweight BMI 30kgm2 individuals with pre-diabetes HbA1c 39-47 mmolmol will all receive once-weekly semaglutide for 26 weeks Semaglutide will be given in escalating doses aiming to reach the maximal dose of 24 mg maximum dosage approved for treatment of overweight but accepting lower maximal tolerable dosage
After 24 weeks of treatment they will be stratified according to their weight loss amplt15 or 15 and based on this stratification block randomized 11 to receive either pramlintide or placebonormal isotonic 09 saline solution in addition to weekly semaglutide Pramlintide will be continuously infused starting at a dosage of 75 mcghour for three days and if tolerated the dosage will be increased to 15 mcghour for the remaining eleven days Previous studies have found measurable changes in appetite after a single dosage of pramlintide and measurable weight loss after two weeks of treatment For the continuous infusion a commercially available insulin pump will be used
At study start and prior to semaglutide treatment body composition REE and gastric emptying rate will be measured Various aspects of appetite will be assessed by the results from the meal tests the taste test appetite assessment and eating related questionnaires An appetite Visual Analog Scale VAS will be measured prior to and following the standardized meal test and the ad libitum meal test Satiety will be assessed by a VAS following the standardized meal test Appetite related sensory specific desire will be assessed by the participants rating of a taste test consisting of a variety of small food samples representing the sensory profiles of sweet sour salt bitter fat umamisavory and spicy respectively The taste test will be performed prior to the ad libitum test and as previously described And satiation will be assessed by measuring calories consumed to reach fullness and terminate the meal at the ad libitum meal test While the Food pleasure scale Yale Food Addiction Scale 20 Dutch Eating Behavior Questionnaire and The Eating Disorder Quality of Life Scale questionnaires will assess hedonic emotional and binge- eating patterns and eating related quality of life The combined results of these physical measurements questionnaires appetite and hunger assessments will be used to identify the participantsamp39 main obesity driver or obesity phenotype similarly as previously described
These tests will be repeated at the end of the study and the results compared The taste test and ad libitum meal test will also be performed after 24 weeks prior to the addition of either pramlintide or placebo
Additionally blood samples will be taken at baseline after 24 weeks and at the end of the study measuring biomarkers related to metabolism bone metabolism and organ specific biomarkers
This is one of the project39s main aims By being able to predict the treatment response one can tailor the obesity treatment to the individual improving the treatment outcome
Amylin is co-secreted with insulin from the pancreas in response to meals It is found to have many similar effects in the body as GLP-1 However their combination especially on appetite food preferences and eating pattern is sparsely investigated This is the other main aim of the project
This clinical study will be a 26 week randomized double-blinded placebo-controlled trial Forty overweight BMI 30kgm2 individuals with pre-diabetes HbA1c 39-47 mmolmol will all receive once-weekly semaglutide for 26 weeks Semaglutide will be given in escalating doses aiming to reach the maximal dose of 24 mg maximum dosage approved for treatment of overweight but accepting lower maximal tolerable dosage
After 24 weeks of treatment they will be stratified according to their weight loss amplt15 or 15 and based on this stratification block randomized 11 to receive either pramlintide or placebonormal isotonic 09 saline solution in addition to weekly semaglutide Pramlintide will be continuously infused starting at a dosage of 75 mcghour for three days and if tolerated the dosage will be increased to 15 mcghour for the remaining eleven days Previous studies have found measurable changes in appetite after a single dosage of pramlintide and measurable weight loss after two weeks of treatment For the continuous infusion a commercially available insulin pump will be used
At study start and prior to semaglutide treatment body composition REE and gastric emptying rate will be measured Various aspects of appetite will be assessed by the results from the meal tests the taste test appetite assessment and eating related questionnaires An appetite Visual Analog Scale VAS will be measured prior to and following the standardized meal test and the ad libitum meal test Satiety will be assessed by a VAS following the standardized meal test Appetite related sensory specific desire will be assessed by the participants rating of a taste test consisting of a variety of small food samples representing the sensory profiles of sweet sour salt bitter fat umamisavory and spicy respectively The taste test will be performed prior to the ad libitum test and as previously described And satiation will be assessed by measuring calories consumed to reach fullness and terminate the meal at the ad libitum meal test While the Food pleasure scale Yale Food Addiction Scale 20 Dutch Eating Behavior Questionnaire and The Eating Disorder Quality of Life Scale questionnaires will assess hedonic emotional and binge- eating patterns and eating related quality of life The combined results of these physical measurements questionnaires appetite and hunger assessments will be used to identify the participantsamp39 main obesity driver or obesity phenotype similarly as previously described
These tests will be repeated at the end of the study and the results compared The taste test and ad libitum meal test will also be performed after 24 weeks prior to the addition of either pramlintide or placebo
Additionally blood samples will be taken at baseline after 24 weeks and at the end of the study measuring biomarkers related to metabolism bone metabolism and organ specific biomarkers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None