Trials / Completed
CompletedNCT02896192
Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity
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 Obesity Due to Bi-Allelic Loss-of-Function POMC or PCSK1 Genetic Mutation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate statistically significant and clinically meaningful effects of setmelanotide on percent body weight change in participants with pro-opiomelanocortin (POMC) deficiency or proprotein convertase subtilisin/kexin type 1 (PCSK1) deficiency obesity due to rare biallelic or loss-of function mutations at the end of 1 year of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | Once daily SC injection |
| DRUG | Placebo | Once daily SC injection |
Timeline
- Start date
- 2017-02-14
- Primary completion
- 2020-05-25
- Completion
- 2020-05-25
- First posted
- 2016-09-12
- Last updated
- 2023-09-21
- Results posted
- 2023-09-21
Locations
7 sites across 7 countries: United States, Belgium, Canada, France, Germany, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02896192. Inclusion in this directory is not an endorsement.