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Study of semaglutide and pramlintide combination therapy for people with obesity and prediabetes

Registered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on treating people with obesity and pre-diabetes. The study will test two medications: semaglutide, which is an anti-diabetic and anti-obesity medication, and pramlintide acetate, which helps stabilize blood glucose levels. The study aims to examine how these medications work together to affect metabolism, body composition, and feelings of hunger and fullness in people with these conditions.

During the study, participants will receive semaglutide for 25 weeks, followed by one week where pramlintide is added to the treatment. Throughout the study, participants will undergo various tests to measure how their body responds to food and how quickly their stomach processes it. One of these tests involves taking paracetamol, a common pain reliever, to measure how fast food moves through the stomach.

The researchers will measure changes in how much food participants eat during test meals and track weight loss throughout the study. They will also monitor how participants feel about their appetite and fullness levels. The study will last approximately 26 weeks, during which the medications will be given through subcutaneous injection under the skin.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment period
You will start taking semaglutide through subcutaneous injection (under the skin).
This phase lasts for 25 weeks (approximately 6 months).
During this period, your weight and body measurements will be monitored regularly.
Step 2
Combined treatment week
After the initial 25 weeks, you will continue taking semaglutide and start additional treatment with pramlintide.
The combined treatment phase lasts for 1 week.
Both medications will be administered through subcutaneous injection.
Step 3
Meal tests
You will participate in meal tests at three points: at the beginning of the study, after 25 weeks, and at the end of week 26.
During these tests, your food consumption will be measured.
You will rate your feelings of hunger and fullness using a simple scale.
Step 4
Stomach emptying assessment
Your stomach emptying rate will be measured using a paracetamol test.
This test will be performed three times: at the start of the study, after 25 weeks, and at the end of week 26.
The test involves taking paracetamol orally and measuring how quickly it enters your bloodstream.
Step 5
Final measurements
At the end of week 26, final measurements will be taken.
Your total weight loss will be calculated both in kilograms and as a percentage of your starting weight.
Your body composition changes will be assessed.

Who can join the trial?

6 criteria

Have a BMI (Body Mass Index) of 30 or higher - BMI is a measure of body fat based on height and weight
Have pre-diabetes with an HbA1c level between 39-47 mmol/mol - HbA1c is a blood test that measures average blood sugar levels over the past 2-3 months
Can be either male or female
Must be over 18 years old
For female participants:
- Must have a negative pregnancy test
- Must agree to use contraception during the study period

Who cannot join the trial?

14 criteria

Body Mass Index (BMI) less than 30 kg/m²
Blood sugar levels (HbA1c) outside the pre-diabetes range of 39-47 mmol/mol
Age below 18 years or above 65 years
Currently pregnant or breastfeeding women
History of severe allergic reactions to similar medications
Current participation in other clinical trials
Significant medical conditions that could interfere with the study results
Use of weight loss medications in the past 3 months
History of bariatric surgery
Uncontrolled high blood pressure
History of eating disorders
Serious psychiatric conditions
Current substance abuse or alcohol dependency
Inability to follow study procedures or attend scheduled visits

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Investigated drugs

Semaglutide is a medication used for weight management and blood sugar control. It helps reduce appetite and food intake by mimicking a natural hormone in your body. It works by helping you feel full for longer periods and can help with weight loss in people with obesity. Pramlintide is a synthetic form of a hormone that helps control blood sugar levels and reduces appetite. It slows down the movement of food through your stomach, which helps you feel full longer and may reduce the amount of food you eat. It is often used in combination with other medications to help manage weight and blood sugar levels in people with obesity and prediabetes. These medications are being studied together to see if their combination provides better results for weight loss and blood sugar control than using semaglutide alone in people who have obesity and prediabetes.

What is already known about the treatment

Semaglutide
A prescription injectable medication that belongs to the class of GLP-1 receptor agonists, primarily used for treating obesity and managing blood sugar levels in people with pre-diabetes. The medication works by mimicking a natural hormone that regulates appetite and food intake, helping to reduce hunger and caloric consumption while slowing down stomach emptying. Semaglutide is administered through subcutaneous injection and has shown significant effectiveness in clinical trials for weight management in people with BMI ≥30 kg/m².
Pramlintide
An injectable synthetic analog of the hormone amylin, used in combination therapy for weight management and blood sugar control. The medication works by slowing gastric emptying, reducing food intake, and helping to regulate post-meal blood glucose levels through multiple mechanisms in the digestive system and brain. Pramlintide is administered via subcutaneous injection and is being studied in combination with semaglutide to potentially enhance weight loss outcomes in people with obesity and pre-diabetes.

Investigated diseases

Obesity
A chronic condition characterized by excessive body fat accumulation, typically measured by a Body Mass Index (BMI) of 30 kg/m² or higher. The condition develops when caloric intake consistently exceeds energy expenditure over time. Obesity affects multiple body systems and can lead to changes in metabolism and hormone regulation. The condition often develops gradually over months or years.
Pre-diabetes
A metabolic condition where blood sugar levels are higher than normal but not high enough to be classified as diabetes. It is characterized by elevated hemoglobin A1C levels between 39-47 mmol/mol (5.7% to 6.4%). Pre-diabetes indicates that the body is having difficulty processing glucose properly. The condition may develop without noticeable symptoms. This state represents an intermediate stage between normal glucose metabolism and diabetes.