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

April 25, 2025 updated by: Janssen Research & Development, LLC

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

The purpose of this study is to assess the safety and tolerability of JNJ-64565111 in adult Men and Women (of non-child bearing potential) with Type 2 Diabetes Mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1 (JNJ-64565111 2.5 nmol/kg or Placebo)
Participants in ratio of 3:1 will receive 2.5 Nanomole Per Kilogram (nmol/kg) JNJ-64565111 or placebo.
Drug: JNJ-64565111
Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Drug: Placebo
Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Experimental: Cohort 2 (JNJ-64565111 3 nmol/kg or Placebo)
Participants in ratio of 3:1 will receive 3.0 nmol/kg JNJ-64565111 or placebo. Dose may be escalated based on review by Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29 but dose will not exceed 3.5 nmol/kg.
Drug: JNJ-64565111
Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Drug: Placebo
Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Experimental: Cohort 3 (JNJ-64565111 3.5 nmol/kg or Placebo)
Participants in ratio of 3:1 will receive 3.5 nmol/kg JNJ-64565111 or placebo. Dose may be escalated based on review by Sponsor and Principal Investigator of blinded safety, tolerability, pharmacokinetic, and (all available) pharmacodynamic data collected up to Day 29 but dose will not exceed 3.5 nmol/kg.
Drug: JNJ-64565111
Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Drug: Placebo
Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Experimental: Cohort 4 (JNJ-64565111 Repeat or Lower Dose or Placebo)
Participants in ratio of 3:1 will receive a dose of JNJ-64565111 or placebo that would be a repeat or lower dose level previously assessed as well-tolerated.
Drug: JNJ-64565111
Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.
Drug: Placebo
Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to Day 72
Up to Day 72

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Incidence of Anti-JNJ-64565111 Antibodies as Measure of Immunogenicity
Time Frame: Up to Day 72
Up to Day 72
Change From Baseline in Body Weight
Time Frame: Baseline, up to Day 72
Baseline, up to Day 72
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to Day 72
Maximum observed plasma concentration (Cmax) will be assessed after first dose and last dose.
Up to Day 72
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to Day 72
Tmax defined as actual sampling time to reach maximum observed analyte concentration will be assessed after first dose and last dose.
Up to Day 72
Area Under Concentration from time zero to the last quantifiable concentration AUC(0-last)
Time Frame: Up to Day 72
AUC from time zero to the last quantifiable concentration will be assessed after first dose and after last dose.
Up to Day 72
Area Under Curve over the dosing interval AUC(0-tau)
Time Frame: Up to Day 72
The AUC [0-tau] is the measure of the plasma drug concentration from time zero to end of dosing interval. It is used to characterize drug absorption. AUC [0-tau] will be assessed after first dose and last dose.
Up to Day 72
Elimination Half-Life (t1/2)
Time Frame: Up to Day 72
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. t1/2 will be assessed after first dose and last dose.
Up to Day 72
Apparent Clearance (CL/F)
Time Frame: Up to Day 72
The Oral Clearance (CL/F) is the clearance based on oral bioavailability. CL/F will be assessed after first dose and last dose.
Up to Day 72
Apparent Volume of Distribution (V/F)
Time Frame: Up to Day 72
Apparent volume of distribution will be assessed after first dose and last dose.
Up to Day 72
Terminal Rate Constant (K)
Time Frame: Up to Day 72
Terminal rate constant will be assessed after first dose and last dose.
Up to Day 72
Average concentration over the dosing interval at steady state (Caverage,ss)
Time Frame: Up to Day 72
The average concentration over the dosing interval at steady state, calculated as AUC(0-tau)/tau and will be assessed after last dose.
Up to Day 72
Minimum Observed Plasma Concentration (Cmin)
Time Frame: Up to Day 72
The Cmin is the minimum observed plasma concentration over the dosing interval at steady state. Cmin will be assessed after last dose.
Up to Day 72
Area Under Curve from time zero extrapolated to infinity AUC(0-inf)
Time Frame: Up to Day 72
AUC from time zero extrapolated to infinity will be assessed after last dose.
Up to Day 72
Accumulation Ratio
Time Frame: Up to Day 72
Accumulation ratio calculated as AUC(0-tau), Day 22 / AUC(0-tau), Day 1 will be assessed after last dose.
Up to Day 72
Change From Baseline in Blood Pressure
Time Frame: Baseline, up to Day 72
Baseline, up to Day 72
Change From Baseline in Heart Rate
Time Frame: Baseline, up to Day 72
Baseline, up to Day 72
Change From Baseline for 24-hour Mean Plasma Glucose
Time Frame: Baseline, Day 26
Mean plasma glucose defined as the total and/or incremental area under the concentration (AUC) time curve over 0 to 24 hours, divided by 24.
Baseline, Day 26
Change From Baseline in Fasting Plasma Glucose (FPG)
Time Frame: Baseline, up to Day 72
Baseline, up to Day 72
Change From Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, up to Day 72
Baseline, up to Day 72
Change From Baseline on Fasting Lipids
Time Frame: Baseline, up to Day 72
Total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein cholesterol (VLDL-C), triglycerides and free fatty acids will be reported.
Baseline, up to Day 72
Change From Baseline in Insulin Secretion
Time Frame: Baseline, Day 26
Baseline, Day 26
Change From Baseline in Insulin Sensitivity
Time Frame: Baseline, Day 26
Baseline, Day 26
Change From Baseline for C-peptide
Time Frame: Baseline, Day 26
Baseline, Day 26
Change From Baseline for Glucagon
Time Frame: Baseline, Day 26
Baseline, Day 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 5, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108166
  • 64565111EDI1001 (Other Identifier: Janssen Research & Development, LLC)
  • 2016-001084-37 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings