DelfaGLP-1 Atlas

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CompletedPhase 1

A Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)

A Randomized, Double-Blind, Parallel, Nested Crossover Study to Investigate the Effect of JNJ-64565111 on Cardiac Repolarization (Corrected QT Interval) Compared With Placebo in Healthy Adults: a Thorough ECG Study Employing Placebo, JNJ-64565111, and a Positive Control (Moxifloxacin)

Asset

Efinopegdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

188

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 25-40•Healthy volunteers

Primary endpoints

•Placebo-Corrected Change from Baseline in QT Interval Corrected for Individual•Change from Time-Matched Baseline in QTc Interval•Heart rate, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03606057
Org study IDCR108477
Secondary ID64565111OBE1002Janssen Research & Development, LLC

Timeline

Milestones

Study start2018-07-13actual
Study first posted2018-07-30actual
Primary completion2019-02-08actual
Study completion2019-02-28actual
Last update posted2020-03-03actual

Assets

Investigational agents

Efinopegdutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Body mass index (BMI) between 25.0 and 40.0 kilogram per square meter ( kg/m^2), inclusive, and a body weight of not less than 80 kg
•Blood pressure (BP) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic
•If a woman, must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening
•If a woman, must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study (from screening through Day 56) or until 30 days after the last dose of study drug for participants that withdraw early from the study
•QRS interval of less than or equal to (<=) 110 milliseconds (ms)
•An average of triplicate 12-lead safety electrocardiogram (ECG) recording, completed within 4 minutes total, consistent with normal cardiac conduction and function at screening, including

1. Normal sinus rhythm (heart rate between 45 and 100 beats per minute [inclusive])

2. QT interval corrected for heart rate according to Fridericia's formula (QTcF) interval between 350 to 450 ms (inclusive)

3. PR interval <= 200 ms

4. ECG morphology consistent with healthy cardiac conduction and function

Exclusion criteria

•Taken any disallowed therapies as defined in a protocol before the planned first dose of study drug
•Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study
•Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram at screening or at admission to the study site
•Known allergies, hypersensitivity, or intolerance to JNJ-64565111, moxifloxacin, or its excipients
•Hepatitis B or C infection
•History of additional risk factors for torsade de pointes or the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (<= 40 years), or sudden infant death syndrome in a first-degree relative (that is biological parent, sibling, or child)

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
10
Cardiometabolic biomarkers
2

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Change from Time-Matched Baseline in Heart Rate (HR)

Time frame:Up to Day 27

Heart rate, change

change from baseline, improvement

Primary/protocol endpoint

Change from Time-Matched Baseline in PR Interval

Time frame:Up to Day 27

change from baseline, descriptive

Safety / tolerability / PK

10 endpoints
Primary/protocol endpoint

Placebo-Corrected Change from Baseline in QT Interval Corrected for Individual Heart Rate (QTcI) on Day 26 Time-Matched Time Points

Time frame:Baseline and Day 26

change from baseline, event

Primary/protocol endpoint

Change from Time-Matched Baseline in QTc Interval

Time frame:Up to Day 27

change from baseline, descriptive

Primary/protocol endpoint

Change from Time-Matched Baseline in QRS Interval

Time frame:Up to Day 27

change from baseline, descriptive

Secondary/protocol endpoint

Cardiac Repolarization as Determined by Mean Change from Time-Matched Baseline in QT Interval Corrected for Individual HR (QTcI) on Day 5

Time frame:Baseline and Day 5

change from baseline, descriptive

Secondary/protocol endpoint

Cardiac Repolarization as Determined by Mean Change from Time-Matched Baseline in QT Interval Corrected For HR Using Fridericia's Formula (QTcF) on Day 5 and Day 26

Time frame:Baseline, Day 5 and Day 26

change from baseline, descriptive

Secondary/protocol endpoint

Maximum Observed Serum Concentration (Cmax)

Time frame:Days 1, 5, 26 and 27

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Observed Serum Concentration (Tmax)

Time frame:Days 1, 5, 26 and 27

Tmax

concentration, descriptive

Secondary/protocol endpoint

Average Serum Analyte Concentration (Cavg)

Time frame:Days 1, 5, 26 and 27

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame:From signing of the informed consent form (ICF) to end of study (approximately 12 weeks)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint/low confidence

QTcI Changes Evaluated Using ECG Assessments versus Serum Concentrations of JNJ-64565111

Time frame:Up to Day 27

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.