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Clinical trials for Melanocortin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    7 result(s) found for: Melanocortin. Displaying page 1 of 1.
    EudraCT Number: 2017-005006-35 Sponsor Protocol Number: RM-493-022 Start Date*: 2018-05-30
    Sponsor Name:Rhythm Pharmaceuticals, Inc.
    Full Title: Long Term Extension Trial of setmelanotide (RM-493) for patients who have completed a trial of Setmelanotide for the treatment of obesity associated with genetic defects upstream of the MC4 recepto...
    Medical condition: Patients with obesity caused by genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway. Human Genetics studies have identified several diseases that are the result of genet...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) NL (Completed) GB (GB - no longer in EU/EEA) BE (Completed) ES (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002320-83 Sponsor Protocol Number: RM-493-012 Start Date*: 2016-09-28
    Sponsor Name:Rhythm Pharmaceuticals, Inc.
    Full Title: An Open Label, 1-Year Trial, including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Early Onset POMC Deficiency Obesi...
    Medical condition: Early onset pro-opiomelanocortin deficiency obesity
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FR (Completed) BE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-002005-36 Sponsor Protocol Number: RM-493-015 Start Date*: 2017-10-30
    Sponsor Name:Rhythm Pharmaceuticals, Inc.
    Full Title: An Open Label, 1-Year Trial, including a Double-Blind Placebo-Controlled Withdrawal Period, of Setmelanotide (RM-493), a Melanocortin 4 Receptor (MC4R) Agonist, in Leptin Receptor (LEPR) Deficiency...
    Medical condition: Early Onset Leptin Receptor (LEPR) Deficiency Obesity due to Bi-Allelic Loss-of-Function LEPR Genetic Mutation
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-006968-11 Sponsor Protocol Number: AP214-CS005 Start Date*: 2009-04-21
    Sponsor Name:Action Pharma A/S
    Full Title: Pharmacokinectics of AP214 Acetate in patients undergoing cardiac surgery. A randomized, double-blind, placebo-controlled sequential ascending dose trial investigating pharmacokinetics, as well as...
    Medical condition: Action Pharma A/S is developing AP214 Acetate for the prevention of postsurgical kidney injury after thoracic aortic aneurysm repair surgery. In phase 2: Patients undergoing cardiac surgery, defin...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056675 Postoperative renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022630-92 Sponsor Protocol Number: AP214-CS007 Start Date*: 2010-11-05
    Sponsor Name:Action Pharma A/S
    Full Title: An Explorative Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Su...
    Medical condition: Action Pharma is developing AP214 Acetate for the prevention of postsurgical kidney injury after cardiac surgery. Trial population is patients with increased risk for development of Kidney Inju...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10022117 - Injury, poisoning and procedural complications 10056675 Postoperative renal failure PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002392-28 Sponsor Protocol Number: RM-493-Supplementation-Therapy Start Date*: 2014-11-28
    Sponsor Name:Charité Univeritaetsmedizin Berlin
    Full Title: Setmelanotide (RM-493) Treatment Trial in Patients with rare genetic disorders of obesity
    Medical condition: Body weight is regulated within the hypothalamus. In rare cases mutations in genes, which are embedded in the signaling cascades of the hypothalamus lead to early onset severe obesity. POMC is one ...
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-004597-65 Sponsor Protocol Number: RM-493-037 Start Date*: 2022-10-20
    Sponsor Name:Rhythm Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind Trial of Two Formulations of Setmelanotide (Daily and Weekly) with a Crossover to Open-Label Once Weekly Setmelanotide in Patients with Specific Gene Defects in ...
    Medical condition: Treatment of obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway. Diseases that are the result of genetic defects affecting the MC4R pathway, con...
    Disease: Version SOC Term Classification Code Term Level
    23.0 10010331 - Congenital, familial and genetic disorders 10084105 Leptin receptor deficiency PT
    23.0 10010331 - Congenital, familial and genetic disorders 10083937 Pro-opiomelanocortin deficiency PT
    20.1 10010331 - Congenital, familial and genetic disorders 10048680 Bardet-Biedl syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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