A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus

December 19, 2019 updated by: Janssen Research & Development, LLC

A Randomized, Double-blind Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Subjects With Type 2 Diabetes Mellitus

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on: the percentage change in body weight from baseline and safety and tolerability.

Study Overview

Status

Status

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

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.
196

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 2

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Central Research Associates, Inc.
    • California
      • Los Angeles, California, United States, 90057
        • National Research Institute
      • Rancho Cucamonga, California, United States, 91730
        • Rancho Cucamonga Clinical Trials
      • Roseville, California, United States, 95661
        • Sierra Clinical Research
      • Spring Valley, California, United States, 91978
        • Encompass Clinical Research
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Miami, Florida, United States, 33183
        • International Research Associates, LLC
      • Miami, Florida, United States, 33122
        • Premeir Clinical Research Institute
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes
      • Orlando, Florida, United States, 32801
        • CNS Healthcare
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Buynak Clinical Research
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • M.D. Medical Research
    • Michigan
      • Flint, Michigan, United States, 48504
        • AAMRC
    • Nevada
      • Henderson, Nevada, United States, 89014
        • ALAS Science Clinical Research
    • Ohio
      • Franklin, Ohio, United States, 45005
        • Prestige Clinical Research
      • Mason, Ohio, United States, 45040
        • Albert J. Weisbrot and Associates
    • Oregon
      • Medford, Oregon, United States, 97504
        • Clinical Research Institute of Southern Oregon, P.C.
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Clinical Research Associates of Central PA, LLC
      • Beaver, Pennsylvania, United States, 15009
        • Heritage Valley Medical Group
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates Inc
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Endocrine Center
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes & Endocrine Center at Medical City
      • Odessa, Texas, United States, 79761
        • Permian Research Foundation
    • Virginia
      • Danville, Virginia, United States, 24541
        • Spectrum Medical, Inc
      • Richmond, Virginia, United States, 23294
        • National Clinical Research
      • Richmond, Virginia, United States, 23219
        • Dominion Medical Associates, Inc.

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body Mass Index (BMI) greater than or equal to (>=) 35 to less than or equal to (<=) 50 kilogram per meter square (kg/m^2) at screening
  • Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical or participant reported history)
  • Hemoglobin A1c of >= 6.5% and <= 9.5% at screening and meets one of the inclusion criteria as: (a) on diet and exercise alone >= 12 weeks prior to screening; (b) on stable dose of single oral antihyperglycemic agent (AHA) or dual-combination oral AHAs for >= 12 weeks prior to screening
  • Women must be either: (a) Postmenopausal, or (b) Permanently sterilized or otherwise be incapable of pregnancy, or (c) Heterosexually active and practicing a highly effective method of birth control, or (d) Not heterosexually active
  • Willing and able to adhere to specific the prohibitions and restrictions

Exclusion Criteria:

  • History of obesity with a known secondary cause (example, Cushing's disease/syndrome)
  • History of Type 1 diabetes mellitus, diabetic ketoacidosis, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • Fasting C-peptide less than (<) 0.7 nanogram per milliliter (ng/mL) at screening
  • Fasting fingerstick glucose of >= 270 milligram per deciliter (mg/dL) (>=15 millimoles per liter [mmol/L]) on Day 1
  • Ongoing, inadequately controlled thyroid disorder as assessed by the investigator's review of the participant's medical history. Participants taking thyroid hormone replacement therapy must be on stable doses for at least 6 weeks before the screening visit

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
  • 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: JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 12-week treatment phase.
Drug: JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
EXPERIMENTAL: JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly for 12-week treatment phase.
Drug: JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.
EXPERIMENTAL: JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly for 12-week treatment phase.
Drug: JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.
PLACEBO_COMPARATOR: Placebo
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 12-week treatment phase.
Drug: Placebo
Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.

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
Measure Description
Time Frame
Percent Change From Baseline in Body Weight at Week 12
Time Frame: Baseline, Week 12
Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.
Baseline, Week 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 16 Weeks
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An TEAE is defined as an AE with an onset after the initiation study medication and before the last study medication date of the double-blind (12-Week) treatment phase plus 35 Days.
Up to 16 Weeks

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
Change From Baseline in Body Weight at Week 12
Time Frame: Baseline, Week 12
Change from baseline in body weight at Week 12 was reported.
Baseline, Week 12
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Weight Loss at Week 12
Time Frame: Week 12
Number of participants with >= 5 % weight loss at Week 12 was reported.
Week 12

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

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.
June 26, 2018

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.
April 5, 2019

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.
April 5, 2019

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 22, 2018

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.
July 12, 2018

First Posted (ACTUAL)

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.
July 16, 2018

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.
January 7, 2020

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.
December 19, 2019

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.
December 1, 2019

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.
  • CR108488
  • 64565111OBE2002 (OTHER: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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.

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