Not recruitingRare disease

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

Fast replyRegistered drugNo placebo

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What is this trial about?

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

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

8 criteria

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 trial?

5 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Universitaire De La Reunion
St Denis, France
Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

Trial locations

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Investigated drugs

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.

Setmelanotide

What is already known about the treatment

Setmelanotide – This medication is administered via injection and is currently being studied in clinical trials for its effectiveness in treating genetic conditions that affect body weight and hunger control. It is primarily indicated for individuals with specific gene variants that impact the melanocortin-4 receptor pathway, which plays a crucial role in regulating appetite and energy balance. Setmelanotide works by activating this receptor, helping to restore normal signaling and reduce excessive hunger. It is classified as a melanocortin receptor agonist, and ongoing research is focused on its potential benefits for weight management in affected individuals.

Investigated diseases

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.