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Long-Term Setmelanotide for Obesity
Study Summary
This trial is to study the safety and tolerability of setmelanotide, a drug used to treat obesity, in patients who have completed a previous trial on the same drug.
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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Who is running the clinical trial?
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- You have thought about or attempted suicide in the past.I or my close family have had melanoma, or I have a history of albinism.If the patient exhibited a clinically meaningful benefit (efficacy) to setmelanotide treatment, and would benefit from continued treatment, he/she may be eligible for the extension study, after discussion with the Sponsor.You are pregnant or breastfeeding.I am over 2 years old and have safely benefited from a prior setmelanotide trial.I have serious skin conditions related to melanoma, not including minor skin cancers.I have a history of serious liver disease.My kidney function is low, with a GFR under 30 mL/min.I have been diagnosed with a psychiatric disorder like schizophrenia or depression.My condition is actively affecting my health.There may be other requirements for participating in the study that are not listed here.
- Group 1: Setmelanotide
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 8 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 52 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 3 Months after you stop receiving the treatment.
Frequently Asked Questions
How is Setmelanotide most often employed?
"Setmelanotide is an effective chronic weight management therapy for patients with obesity, especially those with POMC deficiency obesity."
Are there other ongoing Setmelanotide studies that you are aware of?
"The drug setmelanotide was first studied at the Marshfield Clinic Research Institute in 2018. There have been a total of 12 completed clinical trials since then, with 4 more currently ongoing. A large number of these live trials are based out of Nashville, Tennessee."
To your knowledge, is this research unique in comparison to other similar investigations?
"There have been a total of 4 studies completed for Setmelanotide as of now. They were conducted in 31 cities across 9 different countries, with the first study taking place in 2018. The initial trial was sponsored by Rhythm Pharmaceuticals, Inc. and involved 150 patients. It successfully completed its Phase 2 & 3 drug approval stages. Since then, an additional 12 trials have been carried out."
Are new patients currently being taken in for this experiment?
"The clinical trial is currently recruiting patients, as denoted by information available on clinicaltrials.gov. This research was originally posted on July 15th, 2018 with the most recent update occurring November 9th, 2022."
How many places are responsible for this clinical trial's organization?
"As of now, 20 patients have been enrolled in the trial with locations including Vanderbilt University Medical Center in Nashville, Honor Health Research Institute in Scottsdale, Obesity Institute at Geisinger Clinic in Danville, and other centres."
How many total patients are being surveyed in this investigation?
"That is correct. The clinical trial, which began recruitment on July 15th 2018, is still seeking 150 participants from 20 different sites, according to the latest information available on clinicaltrials.gov."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
What questions have other patients asked about this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- University at Buffalo: < 48 hours
- Baylor College of Medicine: < 48 hours
Average response time
- < 2 Days
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