Trials / Completed
CompletedNCT03287960
Setmelanotide for the Treatment of Leptin Receptor (LEPR) 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 Leptin Receptor (LEPR) Deficiency Obesity Due to Bi-Allelic Loss-of-Function LEPR 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 LEPR deficiency obesity due to rare bi-allelic or loss-of function mutations at the end of 1 year of treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | Once daily subcutaneous injection |
| DRUG | Placebo | Once daily subcutaneous injection |
Timeline
- Start date
- 2018-01-30
- Primary completion
- 2020-09-25
- Completion
- 2020-09-25
- First posted
- 2017-09-19
- Last updated
- 2023-05-23
- Results posted
- 2023-05-23
Locations
6 sites across 6 countries: Canada, France, Germany, Netherlands, Reunion, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03287960. Inclusion in this directory is not an endorsement.