Tailoring Obesity Treatment Trial

What Was Tested

This registered phase 2, phase 3 trial tested Semaglutide and Amylin (Islet Amyloid Polypeptide).

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.

It had two arms (groups): Semaglutide and placebo (active comparator) and Semaglutide and pramlintide (experimental).

All subjects will receive weekly semaglutide inj. for 26 weeks. After 24 weeks of treatment, this group will be randomized to receive placebo, in addition to semaglutide for the last two weeks of the study.

All subjects will receive weekly semaglutide inj. for 26 weeks. After 24 weeks of treatment, this group will be randomized to receive pramlintide, in addition to semaglutide for the last two weeks of the study.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI ≧ 30kg/m2. Male or female. Aged \>18 years of age and \<70 years. Negative pregnancy test, and willing to use contraceptives during the study period.

The full record lists 5 inclusion and 11 exclusion criteria; among the exclusions: presence of diabetes with or without treatment; current or recent (\<6 months) treatment with glp1 ra's; previous gastrointestinal surgery that might affect gastric emptying, nutritional absorption and postprandial gi peptide production.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2025-04-01 with completion listed for 2025-04-01.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in kilocalorie (kCal) consumption at ad libitum meal test, from baseline, to after 26 weeks of semaglutide of which the last two weeks is with the addition of either pramlintide or placebo (time frame: From baseline at the start of the study(week 0), to the end of the study after 26 weeks).

It also tracked 5 secondary outcomes, for example Difference in total weight loss between the subgroups (Obesity phenotypes), Change in appetite and satiety sensations as measured by Visual Analog Scale (VAS) prior to and following the meal tests, Change in gastric emptying rate assessed by paracetamol (acetaminophen) test, Total weight loss and Total weight loss.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Semaglutide and Amylin (Islet Amyloid Polypeptide) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page and the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.