RM-493 ( DrugBank: - )
2 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 193 | Prader-Willi syndrome | 1 |
| 202 | Smith-Magenis syndrome | 3 |
193. Prader-Willi syndrome
Clinical trials : 113 / Drugs : 111 - (DrugBank : 26) / Drug target genes : 48 - Drug target pathways : 102
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02311673 (ClinicalTrials.gov) | February 2015 | 25/11/2014 | Ph 2 Trial to Evaluate Safety & Efficacy of RM-493 in Obese Patients With Prader-Willi Syndrome | A Ph 2, Randomized, Double-Blind, Placebo-controlled Pilot Study to Assess the Effects of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist, in Obese Subjects With Prader-Willi Syndrome (PWS) on Safety, Weight Reduction, and Food-Related Behaviors | Prader-Willi Syndrome | Drug: RM-493;Drug: Placebo | Rhythm Pharmaceuticals, Inc. | NULL | Completed | 16 Years | 65 Years | All | 40 | Phase 2 | United States |
202. Smith-Magenis syndrome
Clinical trials : 9 / Drugs : 10 - (DrugBank : 5) / Drug target genes : 4 - Drug target pathways : 7
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2017-000387-14-GR (EUCTR) | 10/01/2020 | 01/11/2019 | Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity | Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity | - POMC/PCSK1/LEPR heterozygous- POMC/PCSK1/LEPR compound heterozygous or homozygous deficiency obesity- POMC/PCSK1/LEPR composite heterozygous deficiency obesity- Smith-Magenis Syndrome - SH2B1 deficiency obesity- Chromosomal rearrangement of the 16p11.2 locus causing obesity- CPE compound heterozygous or homozygous deficiency obesity- Leptin deficiency obesity with loss of response to metreleptin- SRC1 deficiency obesity- MC4R deficiency obesity;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: setmelanotide Product Code: RM-493 INN or Proposed INN: setmelanotide Other descriptive name: RM-493 | Rhythm Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 222 | Phase 2 | France;United States;Canada;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 2 | EUCTR2017-000387-14-GB (EUCTR) | 24/05/2017 | 17/03/2017 | Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity | Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity | - POMC/PCSK1/LEPR heterozygous- POMC/PCSK1/LEPR compound heterozygous or homozygous deficiency obesity- POMC/PCSK1/LEPR composite heterozygous deficiency obesity- Smith-Magenis Syndrome - SH2B1 deficiency obesity- Chromosomal rearrangement of the 16p11.2 locus causing obesity- CPE compound heterozygous or homozygous deficiency obesity- Leptin deficiency obesity with loss of response to metreleptin- SRC1 deficiency obesity- MC4R deficiency obesity;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: setmelanotide Product Code: RM-493 INN or Proposed INN: setmelanotide Other descriptive name: RM-493 | Rhythm Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | United States;France;Greece;Canada;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 3 | EUCTR2017-000387-14-FR (EUCTR) | 14/03/2019 | Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity | Setmelanotide (RM-493) Phase 2 Treatment Trial in Patients with rare genetic disorders of obesity - Basket Study | -LepR Deficiency Obesity -POMC Heterozygous Deficiency Obesity -POMC Epigenetic Deficiency Obesity -Bardet-Biedl syndrome -Alström syndrome -LEPR Heterozygous Deficiency Obesity -Bi-allelic, homozygous or compound heterozygous genetic status for either the POMC, PCSK1, or LEPR genes, with the loss-of-function variant for each allele conferring a severe obesity phenotype -Smith-Magenis Syndrome -SH2B1 Haploinsufficiency -Carboxypeptidase E deficiency -Leptin deficient obesity;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Product Name: setmelanotide Product Code: RM-493 INN or Proposed INN: setmelanotide Other descriptive name: RM-493 | Rhythm Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Portugal;Greece;Spain;Ireland;Turkey;Israel;United Kingdom;France;Canada;Australia;Germany;Netherlands |