Current partner codePEPTIDESDE
PeptideStat
Menu

Vendors

Compare pricesVendor directoryVendor reviewsDiscount codesLab tests & COAs

Research

ResearchDatabaseClinical trials

Tools

All calculatorsReconstitutionAccumulationUnit converterPeptide chemistry
NCT05046132·Phase 4·INTERVENTIONAL

Study of Setmelanotide Effects on QTc (Corrected QT) Interval in Healthy Participants

SetmelanotideOtherCompleted

Status

Completed

Phase

Phase 4

Enrollment

77

Locations

1

Results

Posted

Publications

0

Study summary

What the protocol is testing.

This was a double-blind, randomized, placebo- and positive-controlled, parallel group, 3-arm study that assessed the potential for therapeutic and supratherapeutic concentrations of setmelanotide to affect the QTc corrected by the Fredericia method (QTcF) interval.

Interventions

Treatment arms and agents.

DRUG

Setmelanotide

Administered once daily via SC injection.

DRUG

Moxifloxacin

Moxifloxacin capsules via oral administration.

DRUG

Oral Placebo

Placebo capsules via oral administration.

DRUG

SC Placebo

Placebo via SC injection.

Timeline

From registration to results.

  1. First posted

    Sep 16, 2021

  2. Study start

    Aug 5, 2021

  3. Primary completion

    Apr 7, 2022

  4. Study completion

    Apr 7, 2022

  5. Results posted

    May 3, 2024

  6. Registry updated

    May 3, 2024

Outcomes

What the study measures.

Primary outcomes

Setmelanotide Concentration-related Placebo-corrected Change From Baseline (CHFB) in Fridericia's Correction (QTcF) at Day 10

Time frame · Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose

Continuous 12-lead digital electrocardiogram (ECG) recording was performed on Baseline and Day 10. ECG analysts were blinded to the treatment, timepoint and participant. QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint.

Setmelanotide Concentration-related Placebo-corrected CHFB in QTcF at Day 16

Time frame · Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

Continuous 12-lead digital ECG recording was performed on Baseline and Day 16. ECG analysts were blinded to the treatment, timepoint and participant. QT interval was corrected for heart rate using QTcF. CHFB in QTcF was calculated at each timepoint.

Secondary outcomes

Placebo-corrected CHFB in Heart Rate (HR) After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10

Time frame · Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hours (hrs) postdose

The CHFB in HR was analyzed using an analysis of variance model (ANOVA) including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate. Placebo corrected values were reported in the inferential statistics.

Placebo-corrected CHFB in HR After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16

Time frame · Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

The CHFB in HR was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10

Time frame · Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

The CHFB in QTcF was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Placebo-corrected CHFB in QTcF Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16

Time frame · Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

The CHFB in QTcF was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10

Time frame · Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

The CHFB in PR was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Placebo-corrected CHFB in PR Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16

Time frame · Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

The CHFB in PR was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 10

Time frame · Baseline and Day 10: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

The CHFB in QRS was analysed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Placebo-corrected CHFB in QRS Intervals After Administration of SC Setmelanotide or Oral Moxifloxacin at Day 16

Time frame · Baseline and Day 16: Pre dose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10,12, 16, 24 hrs postdose

The CHFB in QRS was analyzed using an ANOVA including treatment, time and their interaction as main factors and structuring the residual matrix in order to account for the repeated measurement pattern of the data. HR was considered as covariate.

Number of Participants With at Least One Treatment-Emergent Abnormal Value in HR Intervals After Administration of SC Setmelanotide

Time frame · Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg)

A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: HR (\<40 beats/min, HR\>120 beats/min and Relative CHFB \>25%) Relative CHFB = 100\*(Value-Baseline)/Baseline

Number of Participants With at Least One Treatment-Emergent Abnormal Value in PR Intervals After Administration of SC Setmelanotide

Time frame · Day 10 (for setmelanotide 3 mg) and Day 16 (for setmelanotide 7mg)

A treatment-emergent abnormality/finding was defined as any abnormality/finding not already reported on any of the ECGs collected before the administration. Abnormal findings included: PR (\>220 msec, Relative CHFB \>25%); Relative CHFB = 100\*(Value-Baseline)/Baseline

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
50 Years
Sex
ALL
Healthy volunteers
Yes

Inclusion Criteria: * Participant has body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2), inclusive. * Participant is in good health, as confirmed by no clinically significant findings from medical history, physical examination, 12-lead Electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations, and liver function tests at Screening and Check-in. * Female participants of childbearing potential must be confirmed non-pregnant and agree to use contraception. * Male participants with female partners of childbearing potential must agree to use contraception. Male participants must also not donate sperm during and for 90 days following their participation in the study. * Participant is a nonsmoker (for at least 3 months) with negative urinary cotinine test at Screening and agrees to abstain from alcohol, recreational drugs (including marijuana), and tobacco or nicotine-containing products for the duration of the study. * Participant is able to comprehend and is willing to sign an informed consent form and abide by the study restrictions. Exclusion Criteria: * Participant has sustained systolic blood pressure (SBP) \>150 millimeters of mercury (mmHg) or \<90 mmHg or a diastolic blood pressure (DBP) \>100 mmHg or \<60 mmHg in the supine position at Screening or Day 1 of each study period, respectively. * Participant has supine pulse rate of \<45 beats per minute (bpm) or \>100 bpm. * Participant has abnormal screening ECG indicating a second- or third-degree atrioventricular block, or one or more of the following: QRS\>110 millisecond (msec) , QTcF \>450 msec for males and \>470 msec for females, PR interval \>200 msec. * Participant has a history of risk factors for Torsades de Pointes (TdP), including unexplained syncope, diagnosis or family history of Brugada syndrome or long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesaemia. * Glomerular filtration rate (GFR) \<60 milliliter per minute (mL/min) at Screening. * Participant has significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion). * Participant has history or close family history (parents or siblings) of melanoma or participant history of ocular-cutaneous albinism. * Participant has significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator). * Participant has suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening, a history of a suicide attempt in the last 20 years, or any suicidal behavior in the last month. * Participant has participated in any clinical study with an investigational drug/device within 30 days (or 5 half-lives) prior to the first day of dosing. * Participant was previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide. * Participant has inability to comply with once daily dosing (QD) injection regimen. * Female participants who are breastfeeding or nursing. * Participant has cognitive impairment that, in the investigator's opinion, precludes participation to the study. * Participant is, in investigator's opinion, otherwise not suitable to participate in the study.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Parexel Early Phase Clinical Unit (Los Angeles)

Glendale, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Setmelanotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsSetmelanotide trial dashboard →