GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 1

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Subcutaneous (SC) Injections of JNJ-64565111 in Healthy Male Japanese Participants and to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Participants

A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Japanese Subjects and An Open-label, Single Dose Study to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Subjects

Lead sponsor

Janssen Pharmaceutical K.K.

Asset

Efinopegdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criteria

•BMI 25-40•Male•Healthy volunteers

Primary endpoints

•Treatment-emergent AEs (any)•Part 1•Part 2

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 IDNCT03618160

Org study IDCR108497

Secondary ID64565111NAS1001Janssen Pharmaceutical K.K

Timeline

Milestones

Study start2018-08-06actual

Study first posted2018-08-07actual

Primary completion2019-06-21actual

Study completion2019-06-21actual

Last update posted2025-02-03actual

Assets

Investigational agents

Efinopegdutide

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age20 Years

Maximum age65 Years

SexMale

Healthy volunteersAccepted

Inclusion criteria

•For Part 1 and Part 2, participant must be a Japanese male 20 to 65 years of age, inclusive, at the time of informed consent for screening. For Part 3, participant must be a Caucasian male (defined as white and all of his parents and grandparents are white as determined by participant's verbal report) 20 to 65 years of age, inclusive, at the time of informed consent for screening

•Participant must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during sexual intercourse (even in case of prior vasectomy), or to remain abstinent, and not to donate sperm during the study and for 90 days after study drug administration. Participants should encourage their female partner to use an effective method of contraception (example, prescription oral contraceptives, contraceptive injections, intrauterine device, or contraceptive patch) in addition to the condom used by the male study participant

•Participant must have a body mass index (BMI) ranging from 25 to 40 kilogram per meter square (kg/m^2), weighing 120 kilogram (kg) or less

•Participant must be healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening

•Participant must be a non smoker for at least 1 month prior to screening. A positive urine smoking test (cotinine) at screening and/or admission (Day 2) will lead to exclusion

Exclusion criteria

•Participant having a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiovascular disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), significant pulmonary disease, including bronchospastic respiratory disease, hepatic or renal insufficiency, type 1 diabetes mellitus, type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study result

•Participant has taken any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen, from 14 days before the first dose of the study drug is scheduled until completion of the study

•Participant has received an experimental drug (including investigational vaccines) or used an experimental medical device within 3 months or within a period less than 5 times the drug's half life, whichever is longer, prior to screening

•Participant test positive for human immunodeficiency virus (HIV [positive serology for HIV antigen/antibody]), tests positive for hepatitis B virus surface antigen, or has antibodies to hepatitis C virus (HCV) at screening

•Participant has had major surgery (example, requiring general anesthesia) within 4 months before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 6 months after study drug administration

Endpoints (44)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Part 1 and Part 3: Change From Baseline in Body Weight

Time frame:Baseline to Day 35

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Part 2: Change From Baseline in Body Weight

Time frame:Baseline to Day 72

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Part 1 and Part 3: Change from Baseline in Fasting Plasma Glucose (FPG) Levels

Time frame:Baseline to Day 35

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Part 2: Change From Baseline in Fasting Plasma Glucose (FPG) Levels

Time frame:Baseline to Day 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

12 endpoints

Secondary/protocol endpoint

Part 1 and Part 3: Change From Baseline in Total Cholesterol

Time frame:Baseline to Day 35

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Part 1 and Part 3: Change From Baseline in Low Density Lipoprotein- Cholesterol (LDL-C)

Time frame:Baseline to Day 35

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Part 1 and Part 3: Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C)

Time frame:Baseline to Day 35

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Part 1 and Part 3: Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C)

Time frame:Baseline to Day 35

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Part 1 and Part 3: Change From Baseline in Triglycerides

Time frame:Baseline to Day 35

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Part 1 and Part 3: Change From Baseline in Free Fatty Acids

Time frame:Baseline to Day 35

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Part 2: Change From Baseline in Total Cholesterol

Time frame:Baseline to Day 72

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Part 2: Change From Baseline in Low Density Lipoprotein- Cholesterol (LDL-C)

Time frame:Baseline to Day 72

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Part 2: Change From Baseline in High-Density Lipoprotein-Choelsterol (HDL-C)

Time frame:Baseline to Day 72

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Part 2: Change From Baseline in Very Low Density Lipoprotein-Cholesterol (VLDL-C)

Time frame:Baseline to Day 72

VLDL, change

change from baseline, improvement

Secondary/protocol endpoint

Part 2: Change From Baseline in Triglycerides

Time frame:Baseline to Day 72

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Part 2: Change From Baseline in Free Fatty Acids

Time frame:Baseline to Day 72

Free fatty acids, change

change from baseline, improvement

Safety / tolerability / PK

28 endpoints

Primary/protocol endpoint

Part 1 and Part 3: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability

Time frame:Up to Day 35

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Part 1: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

Part 1: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

Tmax

descriptive

Primary/protocol endpoint

Part 1: Area Under Serum Concentration Curve From Time 0 to Time of the Last Measurable Concentration (AUC[0-Last]) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Part 1: Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC[0-Infinity]) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Part 1: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

Half-life

descriptive

Primary/protocol endpoint

Part 1: Apparent Volume of Distribution (V/F) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

descriptive

Primary/protocol endpoint

Part 1: Total Apparent Clearance (CL/F) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

descriptive

Primary/protocol endpoint

Part 2: Number of Participants With AEs as a Measure of Safety and Tolerability

Time frame:Up to Day 72

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Part 2: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111

Time frame:Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

Part 2: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111

Time frame:Day 1: Predose, 8, 24, 48, 72, 120 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

Tmax

descriptive

Primary/protocol endpoint

Part 2: Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111

Time frame:Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

Half-life

descriptive

Primary/protocol endpoint

Part 2: Apparent Volume of Distribution (V/F) of JNJ-64565111

Time frame:Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

descriptive

Primary/protocol endpoint

Part 2: Total Apparent Clearance (CL/F) of JNJ-64565111

Time frame:Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

descriptive

Primary/protocol endpoint

Part 2: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of JNJ-64565111

Time frame:Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: 72, 96, 144, 168 hours postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Part 2: Observed Serum Concentration Just Prior to the Beginning or the End of a Dosing Interval (Ctrough) of JNJ-64565111

Time frame:Day 8: Predose ; Day 15: Predose; Day 22: Predose, 168 hours postdose

Plasma concentration (steady state)

concentration, descriptive

Primary/protocol endpoint

Part 2: Average Concentration Over the Dosing Interval Tau (T) at Steady State (Caverage,ss) of JNJ-64565111

Time frame:Day 22: Predose, 72, 96, 144, 168 hours postdose

concentration, descriptive

Primary/protocol endpoint

Part 2: Observed Accumulation Index (AR-AUC) of JNJ-64565111

Time frame:Day 1: Predose, 8, 24, 48, 72, 120, 168 hours postdose; Day 22: Predose, 72, 96, 144, 168, 312, 480, 720, 1200 hours postdose

AUC₀–∞

ratio, descriptive

Secondary/protocol endpoint

Part 1 and 3: Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-64565111

Time frame:Predose, 144 and 816 hours postdose

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Part 2: Number of Participants With Anti-Drug Antibodies (ADAs) to JNJ-64565111

Time frame:Predose on Day 1, 8, 15, 22 and then at 144, 480, 720, 1200 hours postdose

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Part 3: Maximum Observed Serum Concentration (Cmax) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

Cmax

concentration, descriptive

Secondary/protocol endpoint

Part 3: Actual Sampling Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

Tmax

descriptive

Secondary/protocol endpoint

Part 3: Area Under Serum Concentration Curve From Time 0 to Time of the Last Measurable Concentration (AUC[0-Last]) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part 3: Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC[0-Infinity]) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Part 3: Apparent Terminal Elimination Rate Constant (Lambda [z]) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

descriptive

Secondary/protocol endpoint

Part 3:Apparent Terminal Elimination Half-Life (t1/2) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

Half-life

descriptive

Secondary/protocol endpoint

Part 3: Apparent Volume of Distribution (V/F) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

descriptive

Secondary/protocol endpoint

Part 3: Total Apparent Clearance (CL/F) of JNJ-64565111

Time frame:Predose, 1, 2, 4, 8, 12, 24, 36, 48, 72, 96, 144, 216, 384, 672, and 816 hours postdose

AUC₀–∞

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.