A study of orismilast alone or combined with semaglutide for weight management in people with obesity

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What is this study about?

This study focuses on treating people with obesity using two medications: orismilast and semaglutide. Orismilast is given as modified-release tablets taken by mouth twice daily, while semaglutide is given as an injection under the skin once per week. Some participants will receive only one of these medications, while others will receive both medications together. Some participants will receive a placebo instead of active medication.

The purpose of this research is to determine how well these medications work for weight management, either alone or in combination. The study will measure changes in body weight and other health measurements over a 16-week treatment period. During the study, participants will take their assigned medication(s) and attend regular check-ups to monitor their progress.

The study will look at various aspects of weight loss, including changes in body measurements, blood pressure, heart rate, and body composition. The research will also examine how these treatments affect certain substances in the blood that are related to inflammation in the body.

1 Initial visit and treatment assignment

Your participation in this 16-week weight management study begins with an initial assessment

You will be randomly assigned to receive one of the following treatment options:

– Orismilast tablets (30 mg) taken twice daily

– Semaglutide (1.0 mg) given as a weekly injection under the skin

– A combination of both medications

– Placebo tablets (inactive tablets that look identical to orismilast)

2 Treatment period

For the next 16 weeks, you will follow your assigned treatment plan:

If taking orismilast: Take one tablet twice per day by mouth

If receiving semaglutide: Receive one injection under the skin each week

Regular measurements will be taken, including:

– Your body weight

– Body measurements (waist and hip)

– Blood pressure and heart rate

– Body composition using a special measuring device

Blood samples will be collected to measure various health markers

3 Final assessment

At week 16, final measurements will be taken to evaluate:

– Changes in your body weight

– Changes in your BMI (body mass index)

– Changes in your body measurements

– Changes in your blood pressure and heart rate

– Final blood tests to measure health markers

Who Can Join the Study?

Must be between 18 and 75 years old
Must have a Body Mass Index (BMI) of 30 or higher (BMI is a measure that uses your height and weight to determine if your weight is healthy)
Must have made at least one previous attempt to lose weight in the past
Can be either male or female
Must not be part of a vulnerable population (such as pregnant women, prisoners, or mentally disabled persons)
Must be willing to take oral medication twice daily and receive weekly injections under the skin (subcutaneous injections)
Must be able to participate in the study for 16 weeks (approximately 4 months)

Who Cannot Join the Study?

Known or suspected allergy to the study medications (orismilast or semaglutide)
Body Mass Index (BMI) less than 30 kg/m²
History of significant heart problems or uncontrolled high blood pressure
Pregnant or breastfeeding women
Current participation in other clinical trials
Major surgery within the past 3 months
Active cancer or cancer treatment within the past 5 years
Severe liver or kidney problems
History of eating disorders
Type 1 diabetes or poorly controlled Type 2 diabetes
Use of other weight loss medications in the past 3 months
History of substance abuse within the past 2 years
Significant mental health conditions that could interfere with the study
Unable to follow study procedures or attend regular visits
History of pancreatitis (inflammation of the pancreas)
Severe gastrointestinal diseases

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Gentofte Hospital	Hellerup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	02.01.2025

Trial locations

Investigated drugs:

Orismilast is an oral medication taken twice daily that is being studied for weight management in people with obesity. It works differently from other weight loss medications, and researchers want to understand how well it helps people lose weight.

Semaglutide is an injectable medication given once weekly under the skin. It is already known to help with weight loss by reducing appetite and helping people feel full longer. It belongs to a class of medications that mimic a natural hormone in the body that regulates blood sugar and appetite.

The trial studies these medications both separately and in combination to see how effectively they work together for weight management in people with obesity. The researchers specifically want to see if using both medications together might lead to better weight loss results than using either medication alone.

Investigated diseases:

Obesity

Obesity – A chronic medical condition characterized by excessive accumulation of body fat that can affect overall health. It occurs when a person’s body mass index (BMI) is 30 or greater, resulting from an imbalance between calorie intake and energy expenditure. The condition develops gradually over time as excess calories are stored as fat tissue throughout the body. Obesity can lead to changes in body composition, including increased total fat mass and visceral fat accumulation. The condition affects various aspects of body functioning, including blood pressure regulation and inflammatory responses in the body.

Trial ID:

2024-517463-23-00

Trial Phase:

Therapeutic exploratory (Phase II)

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A study of orismilast alone or combined with semaglutide for weight management in people with obesity

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?