Study of Setmelanotide for Patients with Obesity Due to Specific Genetic Variants

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What is this study about?

This clinical trial is focused on studying a treatment for certain types of genetic obesity. Obesity is a condition where a person has an excessive amount of body fat, which can lead to various health problems. In this study, the treatment being tested is called setmelanotide, which is given as a solution for injection. The trial is specifically looking at patients who have genetic variants in the POMC, PCSK1, LEPR, NCOA1 (SRC1), or SH2B1 genes. These genes are part of the Melanocortin-4 Receptor Pathway, which plays a role in controlling body weight and hunger.

The purpose of the study is to evaluate how effective setmelanotide is in helping patients lose weight. The trial is designed to compare the effects of setmelanotide with a placebo. Participants will be randomly assigned to receive either the treatment or the placebo. The study will last for about 52 weeks, during which participants will receive regular injections and have their body weight and other health indicators monitored. The trial aims to see if there is a significant change in body weight and other related measures in those treated with setmelanotide compared to those who receive the placebo.

This study is important for understanding how setmelanotide can help people with genetic forms of obesity. By focusing on specific genetic variants, the trial seeks to provide insights into personalized treatment options for individuals with these genetic conditions. The results could lead to better management of obesity in patients with these specific genetic backgrounds.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific genetic variants related to body weight and hunger control.

Participants are required to have a history of obesity from childhood and meet certain body mass index (BMI) criteria.

2 initial assessment

An initial assessment is conducted to establish baseline measurements, including body weight and BMI.

Participants are informed about the study procedures and requirements, including daily injection regimen.

3 treatment phase

Participants receive a daily injection of setmelanotide, a medication designed to influence body weight and hunger.

The medication is administered as a solution for injection under the skin (subcutaneous use) at a concentration of 10 mg/ml.

4 monitoring and evaluation

Participants are monitored regularly to assess changes in body weight and other health indicators.

The primary goal is to evaluate the effectiveness of setmelanotide in reducing body weight over a period of 52 weeks.

5 completion of the study

At the end of the 52-week period, a final assessment is conducted to measure the overall impact of the treatment.

Participants’ experiences and outcomes are documented for further analysis.

Who Can Join the Study?

Patients must have a specific change in certain genes related to body weight control. These genes include POMC, PCSK1, LEPR, NCOA1 (SRC1), and SH2B1. The change must be identified by a certified laboratory and classified as either pathogenic (harmful), likely pathogenic (probably harmful), or a variant of uncertain significance (unclear if harmful).
Patients must be between 6 and 65 years old.
Patients must have obesity that started in childhood. For those 18 years or older, a Body Mass Index (BMI) of 30 or more is required. For those aged 6 to 17, a BMI in the 95th percentile or higher for their age and gender is needed.
Patients and/or their parent or guardian must be able to communicate well with the study team, understand the study requirements, and sign a consent form. Patients who cannot follow the study procedures should not participate.
Patients or their parent/guardian must report that the patient had obesity or was significantly overweight before the age of 6.
Female patients who can have children must not be pregnant and must agree to use a highly effective form of birth control during the study and for 90 days after. This includes methods like hormonal contraception, an intrauterine device (IUD), or sexual abstinence. Male patients with female partners who can have children must also agree to use effective birth control and not donate sperm during and for 90 days after the study.
Patients must have a history of trying to manage their weight through diet and exercise.
Patients must have experienced hyperphagia, which means having an excessive appetite or eating too much, starting in childhood and continuing throughout their life.

Who Cannot Join the Study?

Patients who have a medical condition that affects the way certain messenger materials in the body work, which control body weight and hunger.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as both genders are included in the study.
Patients who are considered 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
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De La Reunion	St Denis	France
Hopital Des Enfants	Toulouse	France
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Hospital Femme Mere Enfant	Bron	France
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital General Universitario De Valencia	Valencia	Spain
General University Hospital Of Patras	Patras	Greece
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Hopital Beaujon	Clichy	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Ezqbfpz Ulayxlllejkp Myjyvdt Cplkefa Rnrzeqyrr (amkphre Mks	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
France	Not recruiting	15.11.2021
Germany	Not recruiting	15.11.2021
Greece	Not recruiting	15.11.2021
Spain	Not recruiting	15.11.2021
The Netherlands	Not recruiting	15.11.2021

Trial locations

Investigated drugs:

Setmelanotide

Setmelanotide is a medication being studied for its ability to help reduce body weight in patients with specific genetic variants. These genetic variants affect the melanocortin-4 receptor pathway, which plays a role in regulating hunger and energy use in the body. The trial aims to see how effective setmelanotide is in helping patients lose weight by targeting these genetic pathways.

Investigated diseases:

Obesity

Obesity due to genetic variants in the MC4R pathway – This condition involves an improper function of certain messenger materials in the body that control body weight and hunger. It is characterized by an imbalance in the signals that regulate appetite and energy expenditure, leading to excessive weight gain. Individuals with this condition may experience persistent hunger and difficulty in maintaining a healthy weight. The progression of this disease can vary, but it often begins in childhood and continues into adulthood. It is considered a rare disease and is linked to specific genetic mutations affecting the melanocortin 4 receptor (MC4R) pathway.

Trial ID:

2023-507634-24-00

Protocol code:

RM-493-035

NCT ID:

NCT05093634

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Setmelanotide for Patients with Obesity Due to Specific Genetic Variants

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?