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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Sydvestjysk Sygehus Esbjerg Denmark

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not yet recruiting
01.01.2025

Trial locations

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.

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.

Trial ID:
2024-510802-10-00
Trial Phase:
Therapeutic use (Phase IV)

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