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

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What is this trial about?

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

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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)
Step 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
Step 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 trial?

7 criteria

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 trial?

16 criteria

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

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Verified sites

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Gentofte Hospital
Verified
Hellerup, Denmark

Trial locations

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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.

What is already known about the treatment

Orismilast
An oral medication administered twice daily that is currently being investigated in clinical trials for weight management in patients with obesity. This novel drug is being studied both alone and in combination with semaglutide, though its exact mechanism of action in weight management is still under investigation. The medication is taken in tablet form with a dosage of 30 mg twice per day.
Semaglutide
A prescription medication administered via subcutaneous injection once weekly, belonging to the GLP-1 receptor agonist class of drugs. It works by mimicking the effects of the natural hormone GLP-1, which helps regulate blood sugar and appetite by affecting areas of the brain that control hunger and satiety. Originally approved for type 2 diabetes treatment, it has shown significant effectiveness in weight management when administered at a dose of 1.0 mg weekly through subcutaneous injection.

Investigated diseases

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.