A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
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
3 other identifiers
interventional
474
6 countries
51
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Mar 2018
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2018
CompletedStudy Start
First participant enrolled
March 26, 2018
CompletedFirst Posted
Study publicly available on registry
April 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2019
CompletedResults Posted
Study results publicly available
February 5, 2020
CompletedFebruary 5, 2020
January 1, 2020
12 months
March 23, 2018
January 14, 2020
January 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in Body Weight at 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)
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 Outcomes (3)
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
Week 26
Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26
Week 26
Change From Baseline in Body Weight at Week 26
Baseline, Week 26
Study Arms (5)
Double-Blind: JNJ-64565111 Dose Level 1
EXPERIMENTALParticipants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.
Double-Blind: JNJ-64565111 Dose Level 2
EXPERIMENTALParticipants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.
Double-Blind: JNJ-64565111 Dose Level 3
EXPERIMENTALParticipants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.
Double-Blind: Placebo
PLACEBO COMPARATORParticipants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.
Open-Label: 3.0 milligram (mg) Liraglutide
ACTIVE COMPARATORParticipant 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.
Interventions
Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
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.
Participants will receive matching placebo SC once-weekly until Week 26.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Care Partners Clinical Research
Jacksonville, Florida, 32277, United States
Advanced Clinical Research
Boise, Idaho, 83642, United States
Medisphere Medical Research Center, Llc
Evansville, Indiana, 47714, United States
L-Marc Research Center
Louisville, Kentucky, 40213, United States
Milford Emergency Associates, Inc.
Marlborough, Massachusetts, 01752, United States
Central New York Clinical Research
Manlius, New York, 13104, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Rapid Medical Research
Cleveland, Ohio, 44122, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Dallas Diabetes Research Center
Dallas, Texas, 75230, United States
Permian Research Foundation
Odessa, Texas, 79761, United States
Advanced Clinical Research
West Jordan, Utah, 84088, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Allegiance Reserach Specialists, LLC
Wauwatosa, Wisconsin, 53226, United States
OLV Ziekenhuis Aalst
Aalst, 9300, Belgium
CSL Arlon
Arlon, 6700, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liège
Liège, 4000, Belgium
AZ Delta
Roeselare, 8800, Belgium
AZ Glorieux Ronse
Ronse, 9600, Belgium
Practimed Medical Center
Tessenderlo, 3980, Belgium
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, N1R 7L6, Canada
Canadian Phase Onward
Toronto, Ontario, M3J 2C5, Canada
Dr. Anil K Gupta Medicine Professional Corporation
Toronto, Ontario, M9V 4B4, Canada
Manna Research
Toronto, Ontario, M9W 4L6, Canada
Manna Research
Lévis, Quebec, G6W 0M5, Canada
Manna Research
Pointe-Claire, Quebec, H9R 4S3, Canada
Clinique des Maladies Lipidiques de Québec
Québec, Quebec, G1V 4W2, Canada
Indywidualna Praktyka Lekarska, Gabinet Leczenia Otyłości i Chorób Dietozależnych
Bialystok, 15-281, Poland
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
NZOZ 'Linia' Centrum Leczenia Zaburzeń Metabolicznych Magdalena Olszanecka-Glinianowicz
Katowice, 40-767, Poland
Nzoz Salvia
Katowice-Ligota, 40-752, Poland
Centrum Zdrowia Metabolicznego Paweł Bogdański
Poznan, 60-589, Poland
Katarina Berndtsson-Blom Ladulaaskliniken
Borås, 50630, Sweden
Intern Medicin
Gothenburg, 41345, Sweden
PTC,Primary care Trial Center
Gothenburg, 42144, Sweden
PharmaSite
Helsingborg, 25220, Sweden
PharmaSite
Malmo, 21152, Sweden
Avdelningen för kliniska prövningar
Örebro, 701 85, Sweden
PTC- Skaraborg
Skövde, 541 50, Sweden
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Ashgate Medical Practice
Chesterfield, S40 4AA, United Kingdom
Hathaway Medical Centre
Chippenham, SN14 6GT, United Kingdom
Aintree University Hospital NHS Trust
Liverpool, L9 7AL, United Kingdom
Clifton Medical Centre
Rotherham, S65 1DA, United Kingdom
Albany House Medical Centre
Wellingborough, NN8 4RW, United Kingdom
Bradford on Avon and Melksham Health Partnership
Wiltshire, BA15 1DQ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director Clinical Leader
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2018
First Posted
April 3, 2018
Study Start
March 26, 2018
Primary Completion
March 8, 2019
Study Completion
March 8, 2019
Last Updated
February 5, 2020
Results First Posted
February 5, 2020
Record last verified: 2020-01