Trial · Interventional
CompletedPhase 1Registry dataStudy to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 57 participants (actual)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Design
- Randomized · Triple masking
- Countries
- Not stated
- Start
- Jan 2012
- Primary completion
- Jan 2014
- Completion
- Jan 2014
- First posted
- 1 May 2015 (estimated)
- Last update posted
- 1 May 2015 (estimated)
- Conditions
- Overweight · Obese
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RM-493 Administered to Healthy, Obese, Non-diabetic Volunteers
NCT02431442Jan 2012 to Jan 2014
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to evaluate the multiple dose safety and tolerability of RM-493 (setmelanotide) as well as pharmacokinetic (PK) and pharmacodynamic (PD; weight loss) profile, in healthy obese patients for 2 to 4 weeks. In addition, one panel of patients with a specific genetic deficiency in the hypothalamic leptin- proopiomelanocortin (POMC) - melanocortin-4 receptor (MC4R) pathway, those with heterozygous partial or full loss of function (LOF) of the MC4R gene, will also be studied. The study drug (RM-493 and placebo) will be administered subcutaneously in a blinded fashion by subcutaneous (SC) infusion or injection.
Interventions
- RM-493Drug
- PlaceboDrug
Arms12
Active comparator
Cohort 1: RM-493 SC Infusion 14 Days
Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 14 days (1 panel, all male subjects)
Active comparator
Cohort 2: RM-493 SC Infusion 28 Days
Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 28 days (1 panel)
Active comparator
Cohort 3: RM-493 SC Infusion 28 Days
Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 28 days (1 panel)
Active comparator
Cohort 4: RM-493 SC Infusion 28 Days
Double-blind RM-493 will be administered at a dose of 0.015 mg/kg/24 hours via subcutaneous continuous infusion for 28 days (1 panel)
Active comparator
Cohort 5: RM-493 SC Injection 14 days
Double-blind RM-493 will be administered at a dose of 0.0075 mg/kg every 12 hours via a subcutaneous injection for 14 days (1 panel)
Active comparator
Cohort 6: RM-493 SC Infusion 28 Days
Double-blind RM-493 will be administered at a dose of 0.01 mg/kg/24 hours via subcutaneous continuous infusion for 28 days (1 panel, heterozygous MC4R subjects)
Placebo comparator
Cohort 1: Placebo SC Infusion 14 Days
Double-blind Placebo will be administered via subcutaneous continuous infusion for 14 days (1 panel, all male subject)
Placebo comparator
Cohort 2: Placebo SC Infusion 28 Days
Double-blind Placebo will be via subcutaneous continuous infusion for 14 days (1 panel)
Placebo comparator
Cohort 3: Placebo SC Infusion 28 Days
Double-blind Placebo will be administered via subcutaneous continuous infusion for 28 days (1 panel)
Placebo comparator
Cohort 4: Placebo SC Infusion 28 Days
Double-blind Placebo will be administered via subcutaneous continuous infusion for 28 days (1 panel)
Placebo comparator
Cohort 5: Placebo SC Injection 14 days
Double-blind Placebo will be administered via a subcutaneous injection every 12 hours for 14 days (1 panel)
Placebo comparator
Cohort 6: Placebo SC Infusion 28 Days
Double-blind Placebo will be administered via subcutaneous continuous infusion for 28 days (1 panel, heterozygous MC4R subjects)
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of adverse events.
Time frame · Day 1 through Day 14 or Day 28 (depending on Cohort)
Secondary outcomes(3)
Pharmacokinetics (PK) Profile
Time frame · Day 1 through Day 14 or Day 28 (depending on Cohort)
Registry description
Frequent PK (trough) sampling throughout the study, including 24-hour inpatient PK profiles at the beginning and end of the study.
Assessment of weight loss based on weight measurements
Time frame · Day 1 through Day 14 or Day 28 (depending on Cohort)
Assessment of blood pressure using Ambulatory blood pressure monitors.
Time frame · Day 1 through Day 14 or Day 28 (depending on Cohort)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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