A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
NCT ID: NCT03486392
Last Updated: 2020-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
474 participants
INTERVENTIONAL
2018-03-26
2019-03-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
Double-Blind: JNJ-64565111 Dose Level 2
Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.
JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
Double-Blind: JNJ-64565111 Dose Level 3
Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.
JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
Double-Blind: Placebo
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.
Placebo
Participants will receive matching placebo SC once-weekly until Week 26.
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.
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.
Interventions
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JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
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.
Placebo
Participants will receive matching placebo SC once-weekly until Week 26.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Central Phoenix Medical Clinic
Phoenix, Arizona, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Care Partners Clinical Research
Jacksonville, Florida, United States
Advanced Clinical Research
Boise, Idaho, United States
Medisphere Medical Research Center, Llc
Evansville, Indiana, United States
L-Marc Research Center
Louisville, Kentucky, United States
Milford Emergency Associates, Inc.
Marlborough, Massachusetts, United States
Central New York Clinical Research
Manlius, New York, United States
Weill Cornell Medicine
New York, New York, United States
Rapid Medical Research
Cleveland, Ohio, United States
Omega Medical Research
Warwick, Rhode Island, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Dallas Diabetes Research Center
Dallas, Texas, United States
Permian Research Foundation
Odessa, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Rainier Clinical Research Center
Renton, Washington, United States
Allegiance Reserach Specialists, LLC
Wauwatosa, Wisconsin, United States
OLV Ziekenhuis Aalst
Aalst, , Belgium
CSL Arlon
Arlon, , Belgium
UZ Antwerpen
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
CHU de Liège
Liège, , Belgium
AZ Delta
Roeselare, , Belgium
AZ Glorieux Ronse
Ronse, , Belgium
Practimed Medical Center
Tessenderlo, , Belgium
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, Canada
Canadian Phase Onward
Toronto, Ontario, Canada
Dr. Anil K Gupta Medicine Professional Corporation
Toronto, Ontario, Canada
Manna Research
Toronto, Ontario, Canada
Manna Research
Lévis, Quebec, Canada
Manna Research
Pointe-Claire, Quebec, Canada
Clinique des Maladies Lipidiques de Québec
Québec, Quebec, Canada
Indywidualna Praktyka Lekarska, Gabinet Leczenia Otyłości i Chorób Dietozależnych
Bialystok, , Poland
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, , Poland
NZOZ 'Linia' Centrum Leczenia Zaburzeń Metabolicznych Magdalena Olszanecka-Glinianowicz
Katowice, , Poland
Nzoz Salvia
Katowice-Ligota, , Poland
Centrum Zdrowia Metabolicznego Paweł Bogdański
Poznan, , Poland
Katarina Berndtsson-Blom Ladulaaskliniken
Borås, , Sweden
Intern Medicin
Gothenburg, , Sweden
PTC,Primary care Trial Center
Gothenburg, , Sweden
PharmaSite
Helsingborg, , Sweden
PharmaSite
Malmo, , Sweden
Avdelningen för kliniska prövningar
Örebro, , Sweden
PTC- Skaraborg
Skövde, , Sweden
Southmead Hospital
Bristol, , United Kingdom
Ashgate Medical Practice
Chesterfield, , United Kingdom
Hathaway Medical Centre
Chippenham, , United Kingdom
Aintree University Hospital NHS Trust
Liverpool, , United Kingdom
Clifton Medical Centre
Rotherham, , United Kingdom
Albany House Medical Centre
Wellingborough, , United Kingdom
Bradford on Avon and Melksham Health Partnership
Wiltshire, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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64565111OBE2001
Identifier Type: OTHER
Identifier Source: secondary_id
2017-003616-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108314
Identifier Type: -
Identifier Source: org_study_id
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