A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants

January 14, 2020 updated by: Janssen Research & Development, LLC

A Randomized, Double-blind Placebo-controlled and Open-label Active-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Subjects

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo after 26 weeks of treatment on the percent change in body weight from baseline and to assess the safety and tolerability, in non-diabetic severely obese participants.

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.
474

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

  • Belgium
      • Aalst, Belgium, 9300
        • OLV Ziekenhuis Aalst
      • Arlon, Belgium, 6700
        • CSL Arlon
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium, 4000
        • CHU de Liège
      • Roeselare, Belgium, 8800
        • AZ Delta
      • Ronse, Belgium, 9600
        • AZ Glorieux Ronse
      • Tessenderlo, Belgium, 3980
        • Practimed Medical Center
  • Canada
    • Ontario
      • Cambridge, Ontario, Canada, N1R 7L6
        • Joanne F. Liutkus Medicine Professional Corporation
      • Toronto, Ontario, Canada, M9W 4L6
        • Manna Research
      • Toronto, Ontario, Canada, M9V 4B4
        • Dr. Anil K Gupta Medicine Professional Corporation
      • Toronto, Ontario, Canada, M3J 2C5
        • Canadian Phase Onward
    • Quebec
      • Levis, Quebec, Canada, G6W 0M5
        • Manna Research
      • Pointe Claire, Quebec, Canada, H9R 4S3
        • Manna Research
      • Québec, Quebec, Canada, G1V 4W2
        • Clinique des maladies lipidiques de Quebec
  • Poland
      • Białystok, Poland, 15-281
        • Indywidualna Praktyka Lekarska, Gabinet Leczenia Otyłości i Chorób Dietozależnych
      • Gdańsk, Poland, 80-546
        • Centrum Badan Klinicznych PI-House sp. z o.o.
      • Katowice, Poland, 40-767
        • NZOZ 'Linia' Centrum Leczenia Zaburzeń Metabolicznych Magdalena Olszanecka-Glinianowicz
      • Katowice-Ligota, Poland, 40-752
        • Nzoz Salvia
      • Poznan, Poland, 60-589
        • Centrum Zdrowia Metabolicznego Paweł Bogdański
  • Sweden
      • Borås, Sweden, 50630
        • Katarina Berndtsson-Blom Ladulaaskliniken
      • Goteborg, Sweden, 42144
        • PTC,Primary care Trial Center
      • Göteborg, Sweden, 41345
        • Intern Medicin
      • Helsingborg, Sweden, 25220
        • PharmaSite
      • Malmo, Sweden, 21152
        • PharmaSite
      • Skövde, Sweden, 541 50
        • PTC- Skaraborg
      • Örebro, Sweden, 701 85
        • Avdelningen för kliniska prövningar
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Chesterfield, United Kingdom, S40 4AA
        • Ashgate Medical Practice
      • Chippenham, United Kingdom, SN14 6GT
        • Hathaway Medical Centre
      • Liverpool, United Kingdom, L9 7AL
        • Aintree University Hospital NHS Trust
      • Rotherham, United Kingdom, S65 1DA
        • Clifton Medical Centre
      • Wellingborough, United Kingdom, NN8 4RW
        • Albany House Medical Centre
      • Wiltshire, United Kingdom, BA15 1DQ
        • Bradford on Avon and Melksham Health Partnership
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Medical Clinic
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Florida
      • Jacksonville, Florida, United States, 32277
        • Care Partners Clinical Research
    • Idaho
      • Boise, Idaho, United States, 83642
        • Advanced Clinical Research
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • L-MARC Research Center
    • Massachusetts
      • Marlborough, Massachusetts, United States, 01752
        • Milford Emergency Associates, Inc.
    • New York
      • Manlius, New York, United States, 13104
        • Central New York Clinical Research
      • New York, New York, United States, 10065
        • Weill Cornell Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Omega Medical Research
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Center
    • Texas
      • Dallas, Texas, United States, 75230
        • Dallas Diabetes Research Center
      • Odessa, Texas, United States, 79761
        • Permian Research Foundation
    • Utah
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Reserach Specialists, LLC

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 square meter (kg/m^2) at the screening visit
  • Stable weight (that is, change of <= 5 percent [%] within 12 weeks before screening based on medical history)
  • 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
  • Woman of childbearing potential have a negative pregnancy test at screening
  • Willing and able to adhere to specific the prohibitions and restrictions

Exclusion Criteria:

  • History of obesity with a known secondary cause (for example, Cushing's disease/syndrome)
  • History of Type 1 diabetes mellitus, Type 2 diabetes mellitus (T2DM), diabetic ketoacidosis (DKA), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy
  • Has a Hemoglobin A1c (HbA1c) of >= 6.5% or fasting plasma glucose (FPG) >= 126 milligrams per deciliter (mg/dL) (>= 7.0 millimoles per liter [mmol/L]) at screening
  • Screening calcitonin of >= 50 picograms per milliliter (pg/mL) personal history or family history of medullary thyroid cancer, or of multiple endocrine neoplasia syndrome type 2 (MEN 2), regardless of time prior to screening
  • History of glucagonoma

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: Double-Blind: JNJ-64565111 Dose Level 1
Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.
Drug: JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
EXPERIMENTAL: Double-Blind: JNJ-64565111 Dose Level 2
Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.
Drug: JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
EXPERIMENTAL: Double-Blind: JNJ-64565111 Dose Level 3
Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.
Drug: JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
PLACEBO_COMPARATOR: Double-Blind: Placebo
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.
Drug: Placebo
Participants will receive matching placebo SC once-weekly until Week 26.
ACTIVE_COMPARATOR: Open-Label: 3.0 milligram (mg) Liraglutide
Participant will receive once-daily doses of 0.6, 1.2, 1.8, 2.4, or 3.0 mg. The participants will receive liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1. Participants will be instructed to increase the dose of liraglutide by 0.6 mg dose increment every 7 days, up to the full dosage of 3.0 mg by Week 5. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.
Drug: Liraglutide
Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.
Other Names:
  • Saxenda

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 26
Time Frame: Baseline, Week 26
Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
Baseline, Week 26
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 30
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. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.
Up to Week 30

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 Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
Time Frame: Week 26
Number of participants with >= 5% body weight loss from baseline to Week 26 were reported.
Week 26
Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26
Time Frame: Week 26
Number of participants with >= 10 % body weight loss from baseline to Week 26 were reported.
Week 26
Change From Baseline in Body Weight at Week 26
Time Frame: Baseline, Week 26
Change from baseline in body weight at Week 26 was reported.
Baseline, Week 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

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.
March 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.
March 8, 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.
March 8, 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).
March 23, 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.
March 30, 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.
April 3, 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.
February 5, 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.
January 14, 2020

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.
January 1, 2020

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.
  • CR108314
  • 64565111OBE2001 (OTHER: Janssen Research & Development, LLC)
  • 2017-003616-39 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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