Tailoring Obesity Treatment Trial

Sponsor
Esbjerg Hospital - University Hospital of Southern Denmark
Study ID
NCT06619015
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

  • Appetite Regulation
  • Obesity
  • PreDiabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Pramlintide Acetate 1 MG/ML — 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 — DRUG
    Semaglutide from 0,25mg/week to 2,4mg/week
  • Sodium Chloride 0.9% Inj — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
Apr 2026
Primary completion
Apr 1, 2025
Completion
Apr 1, 2025

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Semaglutide and placebo
    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.
  • Experimental: Semaglutide and pramlintide
    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.

Primary Outcome Measure

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 ]

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