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Tailoring Obesity Treatment Trial

NCT06619015 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2026-04-17

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

Pramlintide Acetate 1 MG/ML

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.

DRUG

Semaglutide Pen Injector

Semaglutide from 0,25mg/week to 2,4mg/week

DRUG

Sodium Chloride 0.9% Inj

Placebo

Sponsors & Collaborators

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Principal Investigators

  • Claus Bogh Juhl, MD, phd, professor · Head of endocrinology dept.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-04-01
Completion
2025-04-01
FDA Drug
Yes

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06619015 on ClinicalTrials.gov