Short title: TOTT: Tailoring Obesity Treatment Trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Esbjerg Sygehus

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Decision date (initial)

2024-12-03

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Therapy

We have two main aims in the present study:
a) to test the efficacy of semaglutide with or without pramlintide on metabolism, body composition, gastric emptying, various aspects of appetite and satiety in people with obesity and prediabetes.
b) to investigate if phenotyping of obesity can predict the treatment response to semaglutide and pramlintide.

Secondary objectives 1

1. In the present study we also have the sub-aim; to compare the effects of semaglutide or semaglutide in combination with pramlintide on bone turnover in obese individuals with pre-diabetes.

Conditions and MedDRA coding

Obesity (BMI ≧ 30kg/m2)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. BMI ≧ 30kg/m2
2. Pre-diabetes (HbA1c 39-47 mmol/mol)
3. Male or female
4. Aged >18 years of age
5. Negative pregnancy test, and willing to use contraceptives during the study period

Exclusion criteria 11

1. Presence of diabetes with or without treatment.
2. Current or recent (<6 months) treatment with GLP1 RA’s.
3. Previous gastrointestinal surgery that might affect gastric emptying, nutritional absorption and postprandial GI peptide production.
4. History of acute or chronic pancreatitis.
5. Chronic kidney disease.
6. Use of any antipsychotic drugs.
7. Use of any antiresorptive or bone-anabolic drugs or fractures within < 6 months.
8. Use of systemic oral glucocorticoids within < 6 months.
9. Newly (< 3 months) initiated hormonal contraceptive or other hormone therapy.
10. Recent (<3 months) weight loss ≧ 1% of body weight.
11. Presence of Binge eating disorder.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in kilocalorie (kCal) consumption at ad libitum meal test, from baseline, to after 25 weeks, and after 26 weeks of semaglutide treatment, of which the last week is with the addition of pramlintide.

Secondary endpoints 4

1. Total weight loss from baseline, after 25 weeks, and at the end of the study, both as kg and as % of total body weight
2. Difference in total weight loss between the phenotypes
3. Change in appetite and satiety sensations as measured by VAS prior to and following the meal tests performed at baseline, after 25 weeks, and at the end of the study
4. Change in gastric emptying rate assessed by paracetamol test performed at baseline, after 25 weeks, and at the end of the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Esbjerg Sygehus

Sponsor organisation

Esbjerg Sygehus

Address

Finsensgade 35

City

Esbjerg

Postcode

6700

Country

Denmark

Scientific contact point

Organisation

Esbjerg Sygehus

Contact name

Tobias Midvedt Windedal

Public contact point

Organisation

Esbjerg Sygehus

Contact name

Tobias Midvedt Windedal

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications