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Setmelanotide for Obesity
Study Summary
This trialtests a drug to treat obesity in people with certain gene variants. Results will be compared to placebo.
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.Trial Design
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Who is running the clinical trial?
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- I have a genetic variation or deletion in the SH2B1 gene.I have a serious lung, heart, hormone, liver, or cancer-related condition.I have a genetic variant in either the POMC or PCSK1 gene.You have a severe allergy to any ingredient in the study drug.My family or I have a history of melanoma or I have oculocutaneous albinism.My genetic test shows a variant in the NCOA1 gene.I am considered obese based on my BMI.I or my immediate family have a history of melanoma, or I have oculocutaneous albinism.I have serious skin conditions related to melanoma, not including minor skin cancers.I have never participated in a study or taken setmelanotide before.You can't have participated in any other clinical trial with an experimental drug or device within the last 3 months.I often feel an uncontrollable hunger.I have had weight loss surgery recently.I am not pregnant or breastfeeding.My genetic test shows a variant in the NCOA1 gene.I have lost 2% or more of my weight in the last 3 months.I have never participated in a study or taken setmelanotide before.I have a serious health condition affecting my lungs, heart, hormones, liver, or cancer.I have a genetic variant in the POMC or PCSK1 gene.I have a specific genetic change in the LEPR gene.I am between 6 and 65 years old.I was significantly overweight during my childhood.I have serious skin conditions related to melanoma, not including minor skin cancers.I have a genetic variation or deletion in the SH2B1 gene.I have a history of excessive hunger.I have a history of serious liver or kidney disease.I am considered obese based on my BMI.I have a genetic variation in the LEPR gene.I have had serious liver or kidney disease.I (or my guardian) can follow the study's requirements and sign the consent form.I am between 6 and 65 years old.I have lost more than 2% of my weight in the last 3 months.I have had weight loss surgery recently.You have a serious mental illness.You have thought about or attempted suicide in the past.You have previously tried to improve your health by changing your diet and exercising.
- Group 1: NCOA1 (SRC1) variant
- Group 2: POMC or PCSK1 variant
- Group 3: LEPR variant
- Group 4: SH2B1 variant
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Could you tell me the exact number of establishments engaged in this trial?
"As of now, this medical research is accepting participants from twelve different centres. Some cities that are included in the list are Houston, Suwanee and Dearborn along with nine other locales. To make sure your commute is as short as possible, consider joining a trial at the closest location to you."
To what maladies is the POMC or PCSK1 variant usually prescribed?
"POMC or PCSK1 variant are both suitable treatments for chronic weight management therapy, obesity, and POMC deficiency obesity."
Are investigators currently taking on new participants for this research?
"Information available on clinicaltrials.gov indicates that this medical trial is currently accepting applications; the initial posting was made on December 10th 2021, with the last update occuring on November 21st 2022."
Has any research uncovered the implications of POMC or PCSK1 variation?
"In 2018, the Marshfield Clinic Research Institute first evaluated POMC and PCSK1 variants. Since then, 18339 trials have been completed in total - 4 of which are ongoing and conducted primarily from Houston, GA."
Could you provide an estimate of the maximum amount of participants enrolled in this clinical trial?
"To adequately conduct the trial, Rhythm Pharmaceuticals, Inc. requires 400 participants who satisfy its inclusion criteria. Two medical centres have been identified to manage the study: Texas Children's Hospital in Houston and InQuest Medical Research in Suwanee, Michigan."
Who would be an ideal candidate to join this clinical research program?
"This trial is recruiting 400 individuals between the ages of 6 and 65 who are currently living with obesity. Participants must also present a Heterozygous genetic variant in either the POMC or PCSK1 gene, Homozygous, heterozygous, or compound heterozygous variant in SH2B1 gene, 16p11.2 chromosomal deletion encompassing SH2B1 gene; BMI ≥30 kg/m² for those aged 18+ and ≥ 95th percentile for those under 17 years; have tried to treat their condition through diet and exercise before enrolling; agree to use highly effective contraception during the study period as"
What potential risks and benefits come with utilizing a POMC or PCSK1 variant for individuals?
"The POMC or PCSK1 variant has been evaluated with a score of 3, as the Phase 3 trial it is part of provides ample evidence for both its efficacy and safety."
Are participants below the age of 25 eligible to join this research trial?
"This clinical trial is seeking participants aged between 6 and 65. For those outside of this range, there are 206 trials for individuals below 18 years old and 599 studies available to patients above the age of 65."
Is this endeavor a pioneering trial?
"Rhythm Pharmaceuticals, Inc. is behind the initial trial for POMC or PCSK1 variant from 2018, which has since progressed through both Phase 2 and 3 drug approval stages with 150 participants involved. Since then, 38 cities across 10 countries have seen 4 active studies involving a total of 18339 trials conducted in the past four years."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
What questions have other patients asked about this trial?
Why did patients apply to this trial?
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