Study on Petrelintide for Weight Loss in Overweight or Obese Patients with Related Health Issues

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called Petrelintide for individuals who are obese or overweight and have related health issues. The treatment involves a solution for injection that is administered under the skin. The study will compare the effects of different doses of Petrelintide to a placebo, which is a substance with no active medication, to see how they affect body weight when combined with a reduced-calorie diet and increased physical activity.

The main goal of the study is to understand how different doses of Petrelintide can help reduce body weight over a period of 28 weeks. Participants will receive injections once a week and will be monitored to see how their body weight changes. The study will also look at whether participants can achieve a weight loss of 5% or 10% from their starting weight by the end of the study period.

This trial is designed to help researchers find the most effective dose of Petrelintide for managing weight in people with obesity or overweight conditions. Participants will be asked to follow a specific diet and exercise plan while receiving the treatment. The study aims to provide valuable information on how Petrelintide can be used as a part of a weight management program.

1 initial trial phase

Upon joining the trial, participants will begin by receiving a solution for injection containing either petrelintide or a placebo. The injection is administered subcutaneously, which means it is given under the skin.

The trial is designed to be double-blind, meaning neither the participants nor the researchers know who is receiving the active medication or the placebo.

2 medication administration

Participants will receive the injection once a week for a total duration of 28 weeks.

The purpose of the trial is to evaluate the effect of different doses of petrelintide on body weight when combined with a reduced-calorie diet and increased physical activity.

3 diet and activity adjustments

Participants are expected to follow a reduced-calorie diet and engage in increased physical activity throughout the trial period.

These lifestyle changes are essential components of the trial and are intended to complement the effects of the medication.

4 monitoring and assessments

Throughout the trial, participants will be monitored for changes in body weight.

The primary goal is to observe the percentage change in body weight from the start of the trial to the end of the 28-week period.

5 completion of trial

At the end of the 28 weeks, the trial will assess whether participants have achieved a body weight loss of at least 5% or 10% from their initial weight.

The trial is expected to conclude by July 6, 2026.

Who Can Join the Study?

You must sign a form to show you understand and agree to participate in the study before any study-related activities begin.
You need to be at least 18 years old when you sign the consent form.
Your Body Mass Index (BMI) should be 30.0 or higher. If your BMI is 27.0 or higher, you must also have at least one of these conditions: hypertension (high blood pressure) or dyslipidemia (abnormal cholesterol levels), whether treated or not, as decided by the study doctor.
Both men and women can participate. If you are a woman, you can join if you are not able to have children or if you can have children but are not pregnant, do not plan to become pregnant, are not breastfeeding, and agree to use effective birth control methods during the study and for 10 weeks after the last study injection.
You must be able to follow the study rules, including giving yourself the study medication using a vial and syringe.

Who Cannot Join the Study?

Individuals who are not able to follow a reduced-calorie diet and increased physical activity plan.
Individuals who are not within the specified age range for the study.
Individuals who are part of a vulnerable population, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Lukmed 2 Sp. z o.o.	Siedlce	Poland
National Institute Of Endocrinology C.I. Parhon	Bucharest	Romania
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Institutul De Pneumoftiziologie Marius Nasta	Bucharest	Romania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta	Constanta	Romania
Fundeni Clinical Institute	Bucharest	Romania
Fyvpjaxx Dty Vqlnhn Bliwp	Bucharest	Romania
Tov Diqtdz Sbrnlg	Craiova	Romania
Pxukqvzcf Ilfrkyxc Mbwgcrjp Msyzzgjwctyq Scqih Wjvonhsjwfxl I Avpzjnkocjwrv	Warsaw	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	06.11.2024
Romania	Not recruiting	06.11.2024

Trial locations

Investigated drugs:

Petrelintide

Petrelintide is a medication being studied for its potential to help people with obesity or overweight who have weight-related health issues. The trial is investigating how different doses of this medication affect body weight when combined with a reduced-calorie diet and increased physical activity over a period of 28 weeks.

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to weight gain. Over time, this can result in increased body mass index (BMI) and may contribute to various health issues. The progression of obesity can be influenced by factors such as genetics, lifestyle, and environmental factors. It often requires long-term lifestyle changes to manage effectively.

Trial ID:

2024-512549-18-00

Protocol code:

ZP8396-23094

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Petrelintide for Weight Loss in Overweight or Obese Patients with Related Health Issues

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?