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

NCT05046132 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-05-03

Study results available
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Summary

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.

Conditions

  • Healthy

Interventions

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.

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Meeker, MD · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-05
Primary Completion
2022-04-07
Completion
2022-04-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05046132 on ClinicalTrials.gov