DelfaGLP-1 Atlas

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CompletedPhase 1

A Phase 1b Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of JNJ-64565111 in Participants With Type 2 Diabetes Mellitus

A Double-Blind, Randomized, Placebo-Controlled, Multiple 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

2

Recruiting sites

—

Enrollment

39

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI 25-40

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 IDNCT03235219
Org study IDCR108339
Secondary ID64565111EDI1002Janssen Research & Development, LLC

Timeline

Milestones

Study first posted2017-08-01actual
Study start2017-08-01actual
Primary completion2018-02-19actual
Study completion2018-02-19actual
Last update posted2025-04-27actual

Assets

Investigational agents

Efinopegdutide

Study populations

Who this study enrolls

Obesity / overweightType 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
•Hemoglobin A1c (HbA1c) greater than or equal to (>=) 7.0 percent (%) and lesser than or equal to (<=)9.5% at Screening
•On a stable treatment regimen for at least 3 months prior to Screening of (1) diet and exercise, and/or (2) metformin monotherapy (at a dose of at least 1,000 milligram (mg) per day)
•Body mass index (BMI) ranging from 25 to 40 kilogram per square meter (kg/m^2) (inclusive), weighing between 75 and 130 kg (inclusive)
•A woman must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta- hCG) at Screening and Day -2
•Blood pressure (measured after the participant is sitting/ resting quietly for 5 minutes) 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 the average of the first triplicate blood pressure assessment is out of range, up to 2 repeated triplicate assessments are permitted

Exclusion criteria

•History or current diagnosis of acute or chronic pancreatitis
•Familial or personal history of multiple endocrine neoplasia type 2,familial/non-familial medullary thyroid carcinoma
•Donated blood or blood products or lost a significant amount of blood (>500 milliliter [mL]) within 3 months before the first administration of study drug
•History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening
•History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening

Endpoints (29)

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
13
Glycemic / diabetes
11
Cardiometabolic biomarkers
3
Weight & body composition
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Days 8, 15, 22, 28, 29, 35, 42, 52, and 72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline, Days 8, 15, 22, 28, 29, 35, 42, 52, and 72

BMI, change

change from baseline, improvement

Glycemic / diabetes

11 endpoints
Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline, Days 8, 15, 22, 28, 29, 35, 42, 52, and 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Days 8, 15, 22, 28, 29, 35, 42, 52, and 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

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 C-peptide Area Under the Curve (AUC) Calculated From a 6-Hour Mixed Meal Tolerance Test (MMTT)

Time frame:Baseline, Day 26

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total and/or Incremental Plasma Glucose Area Under the Curve (AUC) Calculated From a 6-Hour Mixed Meal Tolerance Test (MMTT)

Time frame:Baseline, Day 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Area Under the Curve (AUC) Calculated From a 6-Hour Mixed Meal Tolerance Test (MMTT)

Time frame:Baseline, Day 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Glucagon Area Under the Curve (AUC) Calculated From a 6-Hour Mixed Meal Tolerance Test (MMTT)

Time frame:Baseline, Day 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline Insulin Secretion as Assessed by the Insulinogenic Index

Time frame:Baseline, Day 26

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Insulin Secretion as Assessed by Homeostasis Model Assessment of Beta Cell Function (HOMA-%B)

Time frame:Baseline, Day 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Sensitivity as Assessed by Matsuda Index

Time frame:Baseline, Day 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Insulin Sensitivity as Assessed by Homeostasis Model Assessment for Insulin Sensitivity (HOMA-%S)

Time frame:Baseline, Day 26

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change From Baseline in Fasting Lipids

Time frame:Baseline, Days 8, 15, 22, 28, 29, 35, 42, 52, and 72

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 24-hour Blood Pressure

Time frame:Baseline and Day 28

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in 24-hour Heart Rate

Time frame:Baseline and Day 28

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

13 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

Maximum Observed Serum Concentration (Cmax)

Time frame:First Dose: Predose (Day 1), and at 8, 24, 48, 72 and 120 hours post-dose (PD); Fourth Dose: predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD.

Cmax

concentration, descriptive

Secondary/protocol endpoint

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame:First Dose: Predose (Day 1), and at 8, 24, 48, 72 and 120 hours post-dose (PD); Fourth Dose: predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

Tmax

descriptive

Secondary/protocol endpoint

Area Under Concentration-Time Curve From Time Zero to the Last Quantifiable Time (AUC [0-last])

Time frame:First Dose: Predose (Day 1), and at 8, 24, 48, 72 and 120 hours post-dose (PD)

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Average Concentration Over the Dosing Interval Tau (T) at Steady State (Caverage,ss)

Time frame:Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Minimum Observed Serum Concentration (Cmin)

Time frame:Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

concentration, descriptive

Secondary/protocol endpoint

Accumulation Ratio

Time frame:First Dose: Predose (Day 1), and at 8, 24, 48, 72 and 120 hours post-dose (PD); Fourth Dose: predose (Day 22), and at 72, 96, 144, 168 hours PD

AUC₀–∞

ratio, descriptive

Secondary/protocol endpoint

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

Time frame:Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168 hours PD

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Apparent Terminal Elimination Half-life (t1/2term)

Time frame:Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

Half-life

descriptive

Secondary/protocol endpoint

Apparent Clearance (CL/F)

Time frame:Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

descriptive

Secondary/protocol endpoint

Apparent Volume of Distribution (V/F)

Time frame:Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

descriptive

Secondary/protocol endpoint

Terminal Rate Constant (Kel)

Time frame:Fourth Dose: Predose (Day 22), and at 72, 96, 144, 168, 312, 480, 720, and 1200 hours PD

descriptive

Secondary/protocol endpoint

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

Time frame:First Dose: Predose (Day 1); Second Dose: predose (Day 8) Third Dose: predose (Day 15); Fourth Dose: predose (Day 22), 144, 480, 720, and 1200 hours post-dose.

Immunogenicity (ADA)

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.