Tailoring Obesity Treatment Trial
NCT06619015 · Withdrawn
Last updated 2026-05-28This clinical trial tests whether adding pramlintide or a placebo to semaglutide for 26 weeks affects calorie intake in adults with obesity and prediabetes.
What this study is testing ClinicalTrials.gov NCT06619015 ↗
Description as written by the study sponsor.
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 N=40. 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.
Treatments tested
- Pramlintide Acetate 1 MG/ML also known as Symlin Drug
Symlin (R) (Pramlintide acetate) 1000mcg/ml, will be administered as a continuous infusion at a rate of 15mcg/hour, equivalent to the daily recommended maximum dosage of 360mcg/day.
- Semaglutide Pen Injector also known as Wegovy Drug
Semaglutide from 0,25mg/week to 2,4mg/week
- Sodium Chloride 0.9% Inj also known as isotonic saline solution Drug
Placebo
| Main thing measured | 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 |
|---|---|
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark |
| Conditions studied | Obesity, Appetite Regulation, PreDiabetes |
| GLP-1 drugs | — |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06619015 ↗