Bardet-Biedl Syndrome, POMC Deficiency
Conditions
Keywords
Melanocortin-4 Receptor Pathway, Genetic Obesity, Hunger, Hyperphagia
Brief summary
A trial to compare the weekly and daily formulations of setmelanotide in participants with genetic defects in the melanocortin-4 receptor pathway.
Detailed description
This study is designed to compare the safety, pharmacokinetics, and efficacy of weekly and daily formulations of setmelanotide in participants with obesity associated with biallelic or heterozygous POMC (pro-opiomelanocortin), PCSK1 (proprotein convertase subtilisin/kexin Type 1), LEPR (leptin receptor) genetic variants, and participants with Bardet-Biedl Syndrome (BBS).
Interventions
DRUGSetmelanotide 2 mg
Administered as SC injection
DRUGSetmelanotide 2.5 mg
Administered as SC injection
DRUGSetmelanotide 3 mg
Administered as SC injection
DRUGSetmelanotide 20 mg
Administered as SC injection
DRUGSetmelanotide 25 mg
Administered as SC injection
DRUGSetmelanotide 30 mg
Administered as SC injection
Sponsors
Rhythm Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Biallelic or heterozygous POMC/PCSK1 or LEPR (PPL) genetic variants or Bardet-Biedl syndrome (BBS), for which they are being treated with QD setmelanotide. * 6 years or older at screening. * Taking the setmelanotide QD formulation for at least 6 months in the RM-493-022 (NCT03013543) study with acceptable safety and tolerability, and dose level. * Participant and/or parent or guardian is able to communicate well with the Investigator, to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent. * Use of a highly effective form of contraception throughout the study and for 90 days following the study. Key
Exclusion criteria
* Glycosylated hemoglobin (HbA1C) \>9.0% at screening. * Anti-obesity medications within 3 months prior to starting the Run-in Period. * History of significant liver disease or liver injury. * Glomerular filtration rate \<30 milliliter per minute (mL/min). * Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions. * Major psychiatric disorders. * Any suicidal ideation or behavior, or any lifetime history of a suicide attempt. * Significant hypersensitivity to any excipient in the study drug. * Inability to comply with the QW and QD injection regimens. * Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing, with the exception of a setmelanotide clinical trial. Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-tau of Setmelanotide After QD Administration in the Run-in Period | Pre-dose (0 hour) and 0.5, 1, 2, 6, 8, 12, 24, 48, 72, 96, 120, and 168-hours postdose at Week 14 | AUC0-tau was recorded from collected blood samples. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
| Mean Setmelanotide Ctrough After QD or QW Administration at Week 22 | 30 minutes predose at Week 22 | Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
| Mean Setmelanotide Ctrough After QD or QW Administration at Week 27 | 30 minutes predose at Week 27 | Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
| Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of Setmelanotide After QD Administration in the Run-in Period | Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, and 8 hours postdose at Week -1 | AUC0-tau was recorded from collected blood samples. |
| Maximum Drug Concentration (Cmax) of Setmelanotide After QD Administration in the Run-in Period | Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1 | Maximum drug concentration determined directly from individual concentration-time data. |
| Cmax of Setmelanotide After QW Administration | Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose at Week 14 | Maximum drug concentration determined directly from individual concentration-time data. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
| Time to Maximum Plasma Concentration (Tmax) of Setmelanotide After QD Administration in the Run-in Period | Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1 | Maximum drug concentration determined directly from individual concentration-time data. |
| Tmax of Setmelanotide After QW Administration | Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose at Week 14 | Maximum drug concentration determined directly from individual concentration-time data. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
| Mean Trough Plasma Concentration (Ctrough) of Setmelanotide After QD or QW Administration at Week 1 | 30 minutes predose at Week 1 | Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
| Mean Setmelanotide Ctrough After QD or QW Administration at Week 5 | 30 minutes predose at Week 5 | Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
| Mean Setmelanotide Ctrough After QD or QW Administration at Week 9 | 30 minutes predose at Week 9 | Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
| Mean Setmelanotide Ctrough After QD or QW Administration at Week 18 | 30 minutes predose at Week 18 | Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Baseline through Week 13 | The injection site evaluation included the identification of areas of erythema, edema, and induration, as well as the presence of localized pain, tenderness, and itching. Baseline was defined as the last available measurement prior to the first dose of setmelanotide or placebo. Injection site reactions frequency of once daily (QD) and once weekly (QW) were reported. Data are reported by dose level (treatment regimen) in the DB Period. Number of participants with injection site reactions according to severity were reported. |
| Number of Participants With ISRs From Week 14 Through Week 27 | Week 14 through Week 27 | The injection site evaluation included the identification of areas of erythema, edema, and induration, as well as the presence of localized pain, tenderness, and itching. Injection site reactions frequency of QD and QW were reported. Data are reported by dose level (treatment regimen) in the OL Period. Number of participants with injection site reactions according to severity were reported. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug administration up to Week 30 | An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The AEs reported after the start of the run-in period were considered TEAEs. |
Countries
Canada, Germany, Netherlands, Puerto Rico, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 20 participants were screened and 19 were randomized and treated in this study. The study consisted of a run-in period of up to 1 week in which the participants received once daily (QD) setmelanotide \[2 milligrams (mg), 2.5 mg, or 3 mg\]; a 13-week double-blind period in which the participants were randomized to either QD or once weekly (QW) setmelanotide; and a 13-week non-randomized open-label period where all participants received open label QW setmelanotide.
Participants by arm
| Arm | Count |
|---|---|
| Setmelanotide 2 mg QD Run-in Period: Participants received SC injection of 2 mg setmelanotide QD for 1 week.
DB Period: Participants received SC injection of 20 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks.
OL Period: Participants received SC injection of 20 mg setmelanotide QW for 13 weeks. | 2 |
| Setmelanotide 2.5 mg QD Run-in Period: Participants received SC injection of 2.5 mg setmelanotide QD for 1 week.
DB Period: Participants received SC injection of 25 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks.
OL Period: Participants received SC injection of 25 mg setmelanotide QW for 13 weeks. | 1 |
| Setmelanotide 3 mg QD Run-in Period: Participants received SC injection of 3 mg setmelanotide QD for 1 week.
DB Period: Participants received SC injection of 3 mg setmelanotide QD and placebo matched to setmelanotide QW or 30 mg setmelanotide QW and placebo matched to setmelanotide QD for 13 weeks.
OL Period: Participants received SC injection of 30 mg setmelanotide QW for 13 weeks. | 16 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Double Blind (DB) Period (13 Weeks) | Withdrawal by parent/guardian | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 |
| Open Label (OL) Period (13 Weeks) | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Setmelanotide 2 mg QD | Setmelanotide 2.5 mg QD | Setmelanotide 3 mg QD | Total |
|---|---|---|---|---|
| Age, Continuous | 20.0 years STANDARD_DEVIATION 12.73 | 19.0 years | 20.8 years STANDARD_DEVIATION 8.3 | 20.6 years STANDARD_DEVIATION 8.16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 1 Participants | 14 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 1 Participants | 1 Participants | 14 Participants | 16 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 10 Participants | 11 Participants |
| Sex: Female, Male Male | 2 Participants | 0 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 | 0 / 16 | 0 / 2 | 0 / 1 | 0 / 9 | 0 / 7 | 0 / 1 | 0 / 1 | 0 / 14 |
| other Total, other adverse events | 0 / 2 | 0 / 1 | 1 / 16 | 2 / 2 | 1 / 1 | 9 / 9 | 6 / 7 | 0 / 1 | 1 / 1 | 10 / 14 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 | 0 / 16 | 0 / 2 | 0 / 1 | 0 / 9 | 0 / 7 | 0 / 1 | 0 / 1 | 0 / 14 |
Outcome results
Primary
Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of Setmelanotide After QD Administration in the Run-in Period
AUC0-tau was recorded from collected blood samples.
Time frame: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, and 8 hours postdose at Week -1
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 3 mg QD | Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUC0-tau) of Setmelanotide After QD Administration in the Run-in Period | 975 hours*ng/mL | Standard Deviation 659 |
Primary
AUC0-tau of Setmelanotide After QD Administration in the Run-in Period
AUC0-tau was recorded from collected blood samples. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: Pre-dose (0 hour) and 0.5, 1, 2, 6, 8, 12, 24, 48, 72, 96, 120, and 168-hours postdose at Week 14
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2 mg QD | AUC0-tau of Setmelanotide After QD Administration in the Run-in Period | 1590 hours*mg/mL | — |
| Setmelanotide 2.5 mg QD | AUC0-tau of Setmelanotide After QD Administration in the Run-in Period | 2260 hours*mg/mL | — |
| Setmelanotide 3 mg QD | AUC0-tau of Setmelanotide After QD Administration in the Run-in Period | 2470 hours*mg/mL | Standard Deviation 2890 |
| Setmelanotide 30 mg QW (QD-QW-QW) | AUC0-tau of Setmelanotide After QD Administration in the Run-in Period | 5010 hours*mg/mL | Standard Deviation 4000 |
Primary
Cmax of Setmelanotide After QW Administration
Maximum drug concentration determined directly from individual concentration-time data. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose at Week 14
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2 mg QD | Cmax of Setmelanotide After QW Administration | 22.4 ng/mL | — |
| Setmelanotide 2.5 mg QD | Cmax of Setmelanotide After QW Administration | 32.7 ng/mL | — |
| Setmelanotide 3 mg QD | Cmax of Setmelanotide After QW Administration | 31.8 ng/mL | Standard Deviation 28.6 |
| Setmelanotide 30 mg QW (QD-QW-QW) | Cmax of Setmelanotide After QW Administration | 57.3 ng/mL | Standard Deviation 33 |
Primary
Maximum Drug Concentration (Cmax) of Setmelanotide After QD Administration in the Run-in Period
Maximum drug concentration determined directly from individual concentration-time data.
Time frame: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1
Population: Participants in the Pharmacokinetic Analysis Set (PKAS) (all participants who received at least 1 dose of setmelanotide and who had a sufficient number of measurable plasma concentrations to permit assessment of noncompartmental parameters) with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2 mg QD | Maximum Drug Concentration (Cmax) of Setmelanotide After QD Administration in the Run-in Period | 29.4 nanograms per milliliter (ng/mL) | Standard Deviation 3.49 |
| Setmelanotide 2.5 mg QD | Maximum Drug Concentration (Cmax) of Setmelanotide After QD Administration in the Run-in Period | 44.8 nanograms per milliliter (ng/mL) | — |
| Setmelanotide 3 mg QD | Maximum Drug Concentration (Cmax) of Setmelanotide After QD Administration in the Run-in Period | 59.9 nanograms per milliliter (ng/mL) | Standard Deviation 29.6 |
Primary
Mean Setmelanotide Ctrough After QD or QW Administration at Week 18
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: 30 minutes predose at Week 18
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 18 | 14.4 ng/mL | — |
| Setmelanotide 2.5 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 18 | 12.6 ng/mL | — |
| Setmelanotide 3 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 18 | 13.6 ng/mL | Standard Deviation 13.9 |
| Setmelanotide 30 mg QW (QD-QW-QW) | Mean Setmelanotide Ctrough After QD or QW Administration at Week 18 | 26.2 ng/mL | Standard Deviation 23.8 |
Primary
Mean Setmelanotide Ctrough After QD or QW Administration at Week 22
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: 30 minutes predose at Week 22
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 22 | 11.9 ng/mL | — |
| Setmelanotide 2.5 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 22 | 14.3 ng/mL | — |
| Setmelanotide 3 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 22 | 17.0 ng/mL | Standard Deviation 15.4 |
| Setmelanotide 30 mg QW (QD-QW-QW) | Mean Setmelanotide Ctrough After QD or QW Administration at Week 22 | 27.9 ng/mL | Standard Deviation 25.4 |
Primary
Mean Setmelanotide Ctrough After QD or QW Administration at Week 27
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: 30 minutes predose at Week 27
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 27 | 14.2 ng/mL | — |
| Setmelanotide 2.5 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 27 | 9.91 ng/mL | — |
| Setmelanotide 3 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 27 | 20.3 ng/mL | Standard Deviation 19.4 |
| Setmelanotide 30 mg QW (QD-QW-QW) | Mean Setmelanotide Ctrough After QD or QW Administration at Week 27 | 32.1 ng/mL | Standard Deviation 23.9 |
Primary
Mean Setmelanotide Ctrough After QD or QW Administration at Week 5
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: 30 minutes predose at Week 5
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2.5 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 5 | 9.54 ng/mL | — |
| Setmelanotide 3 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 5 | 12.2 ng/mL | Standard Deviation 7.62 |
| Setmelanotide 30 mg QW (QD-QW-QW) | Mean Setmelanotide Ctrough After QD or QW Administration at Week 5 | 15.6 ng/mL | Standard Deviation 13.3 |
Primary
Mean Setmelanotide Ctrough After QD or QW Administration at Week 9
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: 30 minutes predose at Week 9
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 9 | 11.1 ng/mL | — |
| Setmelanotide 2.5 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 9 | 6.43 ng/mL | — |
| Setmelanotide 3 mg QD | Mean Setmelanotide Ctrough After QD or QW Administration at Week 9 | 12.3 ng/mL | Standard Deviation 11.4 |
| Setmelanotide 30 mg QW (QD-QW-QW) | Mean Setmelanotide Ctrough After QD or QW Administration at Week 9 | 20.1 ng/mL | Standard Deviation 13.7 |
Primary
Mean Trough Plasma Concentration (Ctrough) of Setmelanotide After QD or QW Administration at Week 1
Ctrough is concentration at the end of the dosing interval, prior to subsequent dose administration. Data are reported by dose level (treatment regimen) in the DB Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: 30 minutes predose at Week 1
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Setmelanotide 2 mg QD | Mean Trough Plasma Concentration (Ctrough) of Setmelanotide After QD or QW Administration at Week 1 | 5.17 ng/mL | Standard Deviation 0.856 |
| Setmelanotide 2.5 mg QD | Mean Trough Plasma Concentration (Ctrough) of Setmelanotide After QD or QW Administration at Week 1 | 4.36 ng/mL | — |
| Setmelanotide 3 mg QD | Mean Trough Plasma Concentration (Ctrough) of Setmelanotide After QD or QW Administration at Week 1 | 11.7 ng/mL | Standard Deviation 13.5 |
| Setmelanotide 30 mg QW (QD-QW-QW) | Mean Trough Plasma Concentration (Ctrough) of Setmelanotide After QD or QW Administration at Week 1 | 16.6 ng/mL | Standard Deviation 16.3 |
Primary
Time to Maximum Plasma Concentration (Tmax) of Setmelanotide After QD Administration in the Run-in Period
Maximum drug concentration determined directly from individual concentration-time data.
Time frame: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose at Week -1
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Setmelanotide 2 mg QD | Time to Maximum Plasma Concentration (Tmax) of Setmelanotide After QD Administration in the Run-in Period | 6.91 hours |
| Setmelanotide 2.5 mg QD | Time to Maximum Plasma Concentration (Tmax) of Setmelanotide After QD Administration in the Run-in Period | 5.88 hours |
| Setmelanotide 3 mg QD | Time to Maximum Plasma Concentration (Tmax) of Setmelanotide After QD Administration in the Run-in Period | 6.02 hours |
Primary
Tmax of Setmelanotide After QW Administration
Maximum drug concentration determined directly from individual concentration-time data. Data are reported by dose level (treatment regimen) in the OL Period and dosing sequence (QD-QD-QW or QD-QW-QW).
Time frame: Pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, and 168 hours postdose at Week 14
Population: Participants in the PKAS with available data were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Setmelanotide 2 mg QD | Tmax of Setmelanotide After QW Administration | 3.93 hours |
| Setmelanotide 2.5 mg QD | Tmax of Setmelanotide After QW Administration | 5.93 hours |
| Setmelanotide 3 mg QD | Tmax of Setmelanotide After QW Administration | 1.98 hours |
| Setmelanotide 30 mg QW (QD-QW-QW) | Tmax of Setmelanotide After QW Administration | 5.95 hours |
Secondary
Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13
The injection site evaluation included the identification of areas of erythema, edema, and induration, as well as the presence of localized pain, tenderness, and itching. Baseline was defined as the last available measurement prior to the first dose of setmelanotide or placebo. Injection site reactions frequency of once daily (QD) and once weekly (QW) were reported. Data are reported by dose level (treatment regimen) in the DB Period. Number of participants with injection site reactions according to severity were reported.
Time frame: Baseline through Week 13
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | None | 2 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | None | 2 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Mild | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | None | 2 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Mild | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Mild | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | None | 2 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | None | 2 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | None | 2 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | None | 2 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Mild | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | None | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Mild | 2 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | None | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | None | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | None | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Mild | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | None | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Mild | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Mild | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Mild | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | None | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Mild | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | None | 7 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | None | 8 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | None | 9 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Mild | 2 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | None | 8 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | None | 6 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Mild | 3 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Mild | 1 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | None | 9 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | None | 4 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Mild | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Mild | 4 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Mild | 1 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Mild | 3 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Moderate | 1 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | None | 6 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Mild | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | None | 6 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | None | 9 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Mild | 3 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Mild | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | None | 9 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Mild | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Mild | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | None | 9 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | None | 6 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Mild | 1 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Moderate | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QW | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | None | 6 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Mild | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Moderate | 1 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | None | 7 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QD | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | None | 4 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | None | 3 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Mild | 2 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Moderate | 1 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Mild | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Induration QW | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Mild | 4 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Moderate | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Moderate | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QD | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Moderate | 1 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | None | 2 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Mild | 4 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Moderate | 1 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QD | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Itching QW | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | None | 5 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Mild | 2 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Moderate | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | None | 5 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QD | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | None | 5 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Mild | 2 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Moderate | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | None | 1 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QD | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | None | 3 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Mild | 3 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Moderate | 1 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Mild | 2 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Erythema QW | Severe | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | None | 7 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Mild | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Edema QD | Moderate | 0 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Pain or Tenderness QW | Moderate | 4 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Injection Site Reactions (ISRs) From Baseline Through Week 13 | Other QW | Mild | 1 Participants |
Secondary
Number of Participants With ISRs From Week 14 Through Week 27
The injection site evaluation included the identification of areas of erythema, edema, and induration, as well as the presence of localized pain, tenderness, and itching. Injection site reactions frequency of QD and QW were reported. Data are reported by dose level (treatment regimen) in the OL Period. Number of participants with injection site reactions according to severity were reported.
Time frame: Week 14 through Week 27
Population: Participants in the Safety Analysis Set with available data were analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | None | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Mild | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Moderate | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Severe | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | None | 1 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Mild | 0 Participants |
| Setmelanotide 2 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | None | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | None | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Mild | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Mild | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Mild | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Moderate | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | None | 1 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Severe | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | None | 13 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Mild | 1 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | None | 12 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Mild | 2 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Erythema QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | None | 13 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Mild | 1 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | None | 14 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | None | 13 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Mild | 1 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | None | 8 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Mild | 4 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Moderate | 2 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Induration QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | None | 14 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Mild | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | None | 10 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Mild | 4 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Itching QW | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | None | 13 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Mild | 1 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QD | Severe | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | None | 8 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Mild | 6 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Pain or Tenderness QW | Moderate | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With ISRs From Week 14 Through Week 27 | Edema QW | Mild | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. The AEs reported after the start of the run-in period were considered TEAEs.
Time frame: From first dose of study drug administration up to Week 30
Population: Participants in the Safety Analysis Set (all participants who received at least 1 dose of protocol-specified study drug) were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Setmelanotide 2 mg QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| Setmelanotide 2.5 mg QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| Setmelanotide 3 mg QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| Setmelanotide 30 mg QW (QD-QW-QW) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 2 Participants |
| DB Period: Setmelanotide 25 mg QW | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| DB Period: Setmelanotide 3 mg QD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 9 Participants |
| DB Period: Setmelanotide 30 mg QW | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 6 Participants |
| OL Period: Setmelanotide 20 mg QW | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| OL Period: Setmelanotide 25 mg QW | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| OL Period: Setmelanotide 30 mg QW | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 10 Participants |