Study of Semaglutide and Glucagon Effects on Energy Expenditure and Glucose Levels in Healthy Volunteers

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What is this study about?

This research study focuses on obesity and examines how different substances affect energy use and blood sugar levels in the body. The study will test two medications: semaglutide, which is given as an injection under the skin, and glucagon, which can be given either through an injection under the skin or directly into a vein.

The purpose of the study is to understand how glucagon influences the body’s energy use and blood sugar changes, particularly when combined with other treatments that affect insulin production. During the study, participants will receive different combinations of treatments including sugar (glucose) taken by mouth, sugar given through a vein, and the study medications. The study will measure how the body uses energy and processes different nutrients after receiving these treatments.

Throughout the study, participants will undergo various measurements including how much energy their body uses while resting, changes in blood sugar levels, and how their body processes different types of nutrients. They will also be monitored for any changes in body weight and any side effects that may occur after receiving the treatments.

1 Initial medication phase

You will receive semaglutide through an injection under the skin (subcutaneous)

This medication helps regulate blood sugar levels and energy use in your body

2 Testing sessions

Your body’s energy use will be measured while resting using a special breathing device (indirect calorimetry)

You will receive different substances through various methods:

– Sugar (glucose) by mouth

– Sugar (glucose) through a vein

– Glucagon through a vein

– Salt water solution (saline) through a vein

Each testing session will be followed by monitoring periods

3 Continuous monitoring

Your blood sugar levels will be tracked continuously using a small sensor (continuous glucose monitor)

Regular blood samples will be taken to measure levels of different substances in your blood including:

– Sugar (glucose)

– Insulin

– Glucagon

– GLP-1 (a hormone that affects blood sugar)

4 Additional measurements

Your body weight will be recorded throughout the study

Urine samples will be collected to measure protein processing in your body

You will need to report any side effects during the weeks following each treatment

5 Study duration

The study runs from June 2024 to June 2025

Multiple visits will be required during this period for treatments and measurements

Who Can Join the Study?

Must be between 18 and 40 years old
Must be male
Must have a BMI (Body Mass Index) between 25 and 34.9 (BMI is a measure of body fat based on height and weight)
Must be willing and able to provide informed consent (written agreement to participate in the study after understanding all aspects of participation)

Who Cannot Join the Study?

History of any chronic diseases (long-term health conditions that require ongoing management)
Current use of any prescription medications that could affect metabolism or blood sugar levels
Female participants (study is only open to male subjects)
Anyone under 18 or over 65 years of age
History of allergic reactions to glucagon or similar substances
Participation in other clinical trials within the past 30 days
Any significant abnormalities in blood tests or medical examination results
History of substance abuse or alcohol dependency
Inability to follow study procedures or attend scheduled visits
Any condition that could interfere with glucose metabolism
Current smoking or use of nicotine products
Significant changes in weight (more than 5%) in the past 3 months
Any acute illness or infection at the time of enrollment
Blood clotting disorders or use of blood-thinning medications
History of fainting during medical procedures

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Pauls Stradins Clinical University Hospital	Riga	Latvia

Trial status

Country	Status	Recruitment Start
Latvia	Not recruiting	01.06.2024

Trial locations

Investigated drugs:

Semaglutide

Glucagon is a hormone medication used to regulate blood sugar levels. In this trial, it is being studied to understand how it affects the body’s energy use and blood glucose levels. Glucagon works in the opposite way to insulin – while insulin lowers blood sugar, glucagon helps raise it when levels are too low.

Glucose (both intravenous and oral forms) is used in this trial as a simple sugar that provides energy to the body. It will be given to participants to compare how the body processes glucose when taken by mouth versus when given directly into the bloodstream, and to see how this interacts with glucagon’s effects.

Investigated diseases:

Obesity

Obesity – A chronic medical condition characterized by excessive accumulation of body fat that may affect a person’s health. The condition develops when energy intake consistently exceeds energy expenditure, leading to weight gain over time. Body fat accumulation can occur throughout the body but is often most noticeable in the abdomen, hips, and thighs. The condition can affect various metabolic processes in the body, including how the body processes glucose and fats. Obesity is typically measured using Body Mass Index (BMI), with a BMI of 30 or greater indicating obesity.

Trial ID:

2024-510885-17-01

Protocol code:

VPP-EM-2022/1-0001

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Semaglutide and Glucagon Effects on Energy Expenditure and Glucose Levels in Healthy Volunteers

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?