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Setmelanotide for Bardet-Biedl Syndrome
Study Summary
This trial is testing setmelanotide, a drug that may help with weight loss, in children aged 2-6 with obesity due to certain genetic conditions. The trial will last for one year to evaluate the safety and effectiveness of the drug.
- Bardet-Biedl Syndrome
- Obesity
- Leprosy Deficiency Obesity
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 15 Patients • NCT03287960Trial Design
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- You are between 2 and 6 years old.You are very overweight for your age and gender, and weigh at least 15 kilograms at the time of joining the study.You have a strong allergic reaction to any ingredient in the study drug.The doctor has noticed that you have had episodes of excessive eating at any point in your life.You have excessive eating or a strong urge to eat more than usual.You or someone in your family has had melanoma (a type of skin cancer), or you have a history of oculocutaneous albinism (a condition that affects skin, hair, and eye color).You have been part of a previous research study that involved using setmelanotide, or you have taken setmelanotide before.You have a medical condition that affects your body weight and it is not under control.You have had a serious liver disease in the past.
- Group 1: Setmelanotide
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does the age limit for this research exclude adults over 30 years old?
"This research is open to children that have not yet turned 5 years old."
To join this experiment, what are the requirements that a person must meet?
"This trial is looking for 12 young patients, aged 2-5, who have already been diagnosed with bardet-biedl syndrome. Candidates must also match the following criteria: POMC, PCSK1, or LEPR deficiency (as confirmed by genetic testing which meets American College of Medical Genetics and Genomics criteria), or BBS as defined by both the Beales Criteria, 1999 and genetic confirmation of homozygous or compound heterozygous loss-off-function mutation in BBS genes. In addition, eligible participants must be obese (BMI ≥97th percentile for age and gender AND body weight of"
How does Setmelanotide compare to other treatments?
"Currently, 4 clinical trials are underway to study the efficacy of setmelanotide. Of these 4, 3 are in Phase 3. Setmelanotide trials are being conducted in 52 different locations, with many taking place in Marshfield, Wisconsin."
Have there been similar trials to this one before?
"Since 2018, Setmelanotide has undergone various clinical trials. The first study, involving 150 patients, was completed in 2018 and sponsored by Rhythm Pharmaceuticals, Inc. After the first study, Setmelanotide received Phase 2 & 3 drug approval. Currently, there are 4 ongoing trials in 31 cities and 9 different countries."
How can interested patients sign up for this research?
"As of right now, this particular trial is not looking for any more participants. However, this may change in the future as the study was posted on February 16th, 2022 and was edited as recently as October 21st, 2022. If you are looking for other trials to participate in, there are 996 trials actively recruiting participants with bardet-biedl syndrome and 4 trials for Setmelanotide that are currently searching for patients."
What are the conditions that Setmelanotide is known to help alleviate?
"Setmelanotide can be used to manage chronic weight, obesity, and even obesity caused by a deficiency in pro-opiomelanocortin."
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