BridgeMD
Short title: TOTT: Tailoring Obesity Treatment Trial
EU CTIS ID: 2024-510802-10-00
What this study is testing
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.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- BMI ≧ 30kg/m2
- Pre-diabetes (HbA1c 39-47 mmol/mol)
- Male or female
- Aged >18 years of age
- Negative pregnancy test, and willing to use contraceptives during the study period
You likely can't join if
- Presence of diabetes with or without treatment.
- Recent (<3 months) weight loss ≧ 1% of body weight.
- Presence of Binge eating disorder.
- 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.
See the full eligibility criteria
- BMI ≧ 30kg/m2
- Pre-diabetes (HbA1c 39-47 mmol/mol)
- Male or female
- Aged >18 years of age
- Negative pregnancy test, and willing to use contraceptives during the study period
- Presence of diabetes with or without treatment.
- Recent (<3 months) weight loss ≧ 1% of body weight.
- Presence of Binge eating disorder.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.