Skip to content

Trial · Interventional

WithdrawnPhase 2/3Registry data

Tailoring Obesity Treatment Trial

Short name TOTT

NCTNCT06619015 (opens ClinicalTrials.gov in a new tab)Other id24/39715Other id2024-510802-10-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 2/3
Enrollment
0 participants (actual)
Sponsor
Esbjerg Hospital - University Hospital of Southern Denmark · Other
Design
Randomized · Triple masking
Countries
1 country

Denmark

Start
1 Apr 2025
Primary completion
1 Apr 2025
Completion
1 Apr 2025
First posted
1 Oct 2024
Last update posted
17 Apr 2026
Conditions
Obesity · Appetite Regulation · PreDiabetes

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026
  1. Ph 2/3

    TOTT

    NCT06619015

    1 Apr 2025 to 1 Apr 2025

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Pramlintide Acetate 1 MG/MLDrug
  • Semaglutide Pen InjectorDrug
  • Sodium Chloride 0.9% InjDrug

Arms2

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. 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

Secondary outcomes(5)

  1. Difference in total weight loss between the subgroups (Obesity phenotypes)

    Time frame · From baseline (week 0) to end of study (week 26)

  2. Change in appetite and satiety sensations as measured by Visual Analog Scale (VAS) prior to and following the meal tests

    Time frame · From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)

    Registry description

    The meal test will be performed at baseline, after 24 weeks and at the end of the study(week 26). Prior to and following the meal tests a VAS measuring appetite and satiety sensation will be answered.

  3. Change in gastric emptying rate assessed by paracetamol (acetaminophen) test

    Time frame · From baseline (week 0) to end of study(week 26)

    Registry description

    The gastric emptying test will be performed at baseline (week 0) and at the end of the study (week26).

  4. Total weight loss

    Time frame · From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)

    Registry description

    Total weight loss from baseline, after 24 weeks, and at the end of the study( week 26) The results will be repoted as percentage (%) weight loss.

  5. Total weight loss

    Time frame · From baseline(week 0) to after 24 weeks, and to the end of the study(week 26)

    Registry description

    Total weight loss from baseline, after 24 weeks, and at the end of the study( week 26) The results will be repoted as total weight loss in Kg

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * BMI ≧ 30kg/m2 * HbA1c 39-47 mmol/mol (pre-diabetes) * Male or female * Aged \>18 years of age and \<70 years * Negative pregnancy test, and willing to use contraceptives during the study period Exclusion Criteria: * 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 * History of acute or chronic pancreatitis * Chronic kidney disease * Use of any antipsychotic drugs * Use of any antiresorptive or bone-anabolic drugs or fractures within \< 6 months * Use of systemic oral glucocorticoids within \< 6 months * Newly (\< 3 months) initiated hormonal contraceptive or other hormone therapy * Recent (\<3 months) weight loss ≧ 1% of body weight * Presence of Binge eating disorder

PepBank is a research reference. Talk to a doctor before you use any peptide.