DelfaGLP-1 Atlas

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TerminatedPhase 1

Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Type 2 Diabetes Mellitus (T2DM)

A Double-Blind, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-64565111 in Men and Women With Type 2 Diabetes Mellitus

Asset

Efinopegdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

24

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥6.5%

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT02862431
Org study IDCR108166
Secondary ID2016-001084-37
Secondary ID64565111EDI1001Janssen Research & Development, LLC

Timeline

Milestones

Study start2016-07-12actual
Study first posted2016-08-11estimated
Primary completion2016-11-29actual
Study completion2016-12-05actual
Last update posted2025-04-27actual

Assets

Investigational agents

Efinopegdutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis of Type 2 Diabetes Mellitus (T2DM) at least 3 months prior to Screening
•On a stable treatment regimen at least 3 months prior to Screening of (1) diet and exercise, or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg) per day)
•Blood pressure between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and between 60 and 100 mmHg diastolic, inclusive at Screening (sitting) and Day -2 (supine). If blood pressure is out of range, up to 2 repeated assessments are permitted
•HbA1c greater than or equal to 6.5% and less than 8.5% at Screening
•Females of non-childbearing potential

Exclusion criteria

•History of, or currently active, significant illness or medical disorders, including cardiovascular disease (including cardiac arrhythmias, myocardial infarction, stroke, peripheral vascular disease), hematological disease (example, von Willebrand's disease or other bleeding disorders), respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmologic disorders, neoplastic disease, skin disorder, renal disorder, or any other illness that the Principal Investigator (PI) considers should exclude the participant or that could interfere with the interpretation of the study results
•Previous surgical treatment for obesity (example, gastric bypass, gastric banding)
•History of diabetic neuropathy with signs of gastroparesis and/or known proliferative retinopathy or maculopathy
•History or current diagnosis of acute or chronic pancreatitis
•History of an invasive cardiovascular surgical procedure including, but not limited to, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI)

Endpoints (25)

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
14
Glycemic / diabetes
6
Cardiometabolic biomarkers
3
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, up to Day 72

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints
Secondary/protocol endpoint

Change From Baseline for 24-hour Mean Plasma Glucose

Time frame:Baseline, Day 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline, up to Day 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, up to Day 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Change From Baseline in Insulin Secretion

Time frame:Baseline, Day 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Sensitivity

Time frame:Baseline, Day 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline for C-peptide

Time frame:Baseline, Day 26

C-peptide AUC

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change From Baseline in Blood Pressure

Time frame:Baseline, up to Day 72

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Heart Rate

Time frame:Baseline, up to Day 72

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline on Fasting Lipids

Time frame:Baseline, up to Day 72

change from baseline, improvement

Safety / tolerability / PK

14 endpoints
Primary/protocol endpoint

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

Time frame:Up to Day 72

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants With Incidence of Anti-JNJ-64565111 Antibodies as Measure of Immunogenicity

Time frame:Up to Day 72

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Maximum Observed Plasma Concentration (Cmax)

Time frame:Up to Day 72

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame:Up to Day 72

Tmax

descriptive

Secondary/protocol endpoint

Area Under Concentration from time zero to the last quantifiable concentration AUC(0-last)

Time frame:Up to Day 72

concentration, descriptive

Secondary/protocol endpoint

Area Under Curve over the dosing interval AUC(0-tau)

Time frame:Up to Day 72

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Elimination Half-Life (t1/2)

Time frame:Up to Day 72

Half-life

descriptive

Secondary/protocol endpoint

Apparent Clearance (CL/F)

Time frame:Up to Day 72

descriptive

Secondary/protocol endpoint

Apparent Volume of Distribution (V/F)

Time frame:Up to Day 72

descriptive

Secondary/protocol endpoint

Terminal Rate Constant (K)

Time frame:Up to Day 72

descriptive

Secondary/protocol endpoint

Average concentration over the dosing interval at steady state (Caverage,ss)

Time frame:Up to Day 72

concentration, descriptive

Secondary/protocol endpoint

Minimum Observed Plasma Concentration (Cmin)

Time frame:Up to Day 72

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Area Under Curve from time zero extrapolated to infinity AUC(0-inf)

Time frame:Up to Day 72

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio

Time frame:Up to Day 72

AUC₀–∞

ratio, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change From Baseline for Glucagon

Time frame:Baseline, Day 26

change from baseline, 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.