Study Comparing Tirzepatide and Semaglutide for Weight Loss in Adults with Obesity or Overweight and Related Health Issues

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What is this study about?

This clinical trial is focused on studying the effects of a medication called Tirzepatide (also known by its code name LY3298176) in adults who have obesity or are overweight with additional health issues related to their weight. The study will compare Tirzepatide to another medication called Semaglutide, which is also used to help with weight loss. Both medications are given as a solution for injection.

The purpose of the study is to see if Tirzepatide is more effective than Semaglutide in helping participants lose weight. Participants will receive either Tirzepatide, Semaglutide, or a placebo over a period of time. The study will monitor changes in body weight, waist size, and body mass index (BMI), which is a measure of body fat based on height and weight. The study will also look at how many participants achieve significant weight loss, such as losing 10% or more of their body weight.

Participants will be involved in the study for up to 72 weeks, during which they will receive regular injections and attend follow-up visits to track their progress. The study aims to provide valuable information on the effectiveness and safety of Tirzepatide compared to Semaglutide for weight management in individuals with obesity or overweight conditions.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as having obesity or being overweight with conditions like high blood pressure or high cholesterol.

You will receive detailed information about the study, including the medications involved and the procedures you will undergo.

2 randomization

You will be randomly assigned to receive either tirzepatide or semaglutide. This means you will not choose which medication you receive, and neither will the study staff.

This process ensures that the study results are unbiased and reliable.

3 medication administration

You will receive your assigned medication as a solution for injection. The medication will be administered under the skin, similar to how insulin is given.

If you are assigned semaglutide, you will receive a dose of 2.4 mg once a week. If you are assigned tirzepatide, the dose will be determined based on the maximum tolerated dose (MTD) for you.

4 regular follow-up visits

You will attend regular follow-up visits throughout the study. These visits are important for monitoring your health and the effects of the medication.

During these visits, your weight, waist circumference, and other health indicators will be measured to track changes from the start of the study.

5 end of study

The study is expected to end by September 30, 2024. At the end of the study, you will have a final visit where all necessary assessments will be completed.

The results of the study will help determine the effectiveness and safety of tirzepatide compared to semaglutide in achieving weight loss.

Who Can Join the Study?

Must have obesity.
Must have overweight with at least one of the following conditions:
- Obstructive sleep apnea (a condition where breathing stops and starts during sleep)
- High blood pressure (also known as hypertension)
- High cholesterol (high levels of fats in the blood)
- Heart disease (any disorder that affects the heart)
Open to both male and female participants.

Who Cannot Join the Study?

Patients who have a history of severe allergic reactions to any of the study medications.
Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication or lifestyle changes.
Patients with a history of heart attack or stroke within the last 6 months.
Patients with severe kidney disease, which means their kidneys are not working well.
Patients with severe liver disease, which means their liver is not functioning properly.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of certain types of cancer, except for skin cancer that is not melanoma.
Patients with a history of drug or alcohol abuse within the last year.
Patients who are unable to follow the study procedures or attend the required visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Poland
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Algemeen Ziekenhuis Delta	Roeselare	Belgium
InnoDiab Forschung GmbH	Essen	Germany
Algemeen Ziekenhuis Damiaan Oostende	Ostend	Belgium
Ambenet GmbH Das Ambulante Behandlungsnetz	Leipzig	Germany
Medizentrum Essen Borbeck	Essen	Germany
NZOZ Medica	Lublin	Poland
ClinPhenomics CVC GmbH	St. Ingbert	Germany
Utumnoeuwj Ol Aitvosx	Edegem	Belgium
Cvgaauz Bwqud Kwywwzgcpsy Piocosmx Sjh z oolw	Gdansk	Poland
Pithbttwgjxfy Du Uclxqr Wmlwsxvz De Doinpoh Drbd Uwg Pzta Dg Jsjj Avvzes	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	30.01.2023
Germany	Not recruiting	30.01.2023
Poland	Not recruiting	30.01.2023

Trial locations

Investigated drugs:

Tirzepatide is a medication being studied for its ability to help people lose weight. It works by mimicking certain hormones in the body that help control blood sugar levels and appetite. This medication is being tested to see if it can help people with obesity or who are overweight to lose weight more effectively than other treatments.

Semaglutide is another medication used in this study, which is already known to help with weight loss. It works by helping to regulate appetite and food intake, making people feel fuller after eating. This medication is being compared to tirzepatide to see which one is more effective in helping people lose weight.

Investigated diseases:

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this imbalance results in the storage of excess energy as fat. The progression of obesity can lead to increased body mass index (BMI) and waist circumference. As the condition advances, it may contribute to the development of related health issues. Obesity is often measured by BMI, with a BMI of 30 or higher indicating obesity.

Overweight – Overweight is a condition where an individual has more body weight than is considered healthy for their height. It occurs when there is an imbalance between calories consumed and calories expended, leading to excess body weight. This condition is often assessed using the body mass index (BMI), with a BMI between 25 and 29.9 indicating overweight. Over time, being overweight can lead to increased fat accumulation and changes in body composition. The progression of overweight can increase the risk of developing obesity and related health conditions. Monitoring weight and waist circumference can help track changes in this condition.

Trial ID:

2022-501106-35-00

Protocol code:

17203

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Tirzepatide and Semaglutide for Weight Loss in Adults with Obesity or Overweight and Related Health Issues

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?