A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT03486392
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 474
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double-Blind: JNJ-64565111 Dose Level 3 JNJ-64565111 Dose Level 3 Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase. Double-Blind: JNJ-64565111 Dose Level 1 JNJ-64565111 Dose Level 1 Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase. Double-Blind: JNJ-64565111 Dose Level 2 JNJ-64565111 Dose Level 2 Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase. Double-Blind: Placebo Placebo Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase. Open-Label: 3.0 milligram (mg) Liraglutide 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.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight at Week 26 Baseline, Week 26 Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Body Weight at Week 26 Baseline, Week 26 Change from baseline in body weight at Week 26 was reported.
Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26 Week 26 Number of participants with \>= 5% body weight loss from baseline to Week 26 were reported.
Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26 Week 26 Number of participants with \>= 10 % body weight loss from baseline to Week 26 were reported.
Trial Locations
- Locations (47)
CSL Arlon
🇧🇪Arlon, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
Clinique des Maladies Lipidiques de Québec
🇨🇦Québec, Quebec, Canada
Nzoz Salvia
🇵🇱Katowice-Ligota, Poland
UZ Antwerpen
🇧🇪Edegem, Belgium
Practimed Medical Center
🇧🇪Tessenderlo, Belgium
Manna Research
🇨🇦Pointe Claire, Quebec, Canada
Indywidualna Praktyka Lekarska, Gabinet Leczenia Otyłości i Chorób Dietozależnych
🇵🇱Białystok, Poland
CHU de Liège
🇧🇪Liège, Belgium
AZ Glorieux Ronse
🇧🇪Ronse, Belgium
L-Marc Research Center
🇺🇸Louisville, Kentucky, United States
Rapid Medical Research
🇺🇸Cleveland, Ohio, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
UZ Leuven
🇧🇪Leuven, Belgium
Centrum Zdrowia Metabolicznego Paweł Bogdański
🇵🇱Poznan, Poland
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
🇺🇸West Jordan, Utah, United States
Central New York Clinical Research
🇺🇸Manlius, New York, United States
Milford Emergency Associates, Inc.
🇺🇸Marlborough, Massachusetts, United States
Medisphere Medical Research Center, Llc
🇺🇸Evansville, Indiana, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Permian Research Foundation
🇺🇸Odessa, Texas, United States
Dallas Diabetes Research Center
🇺🇸Dallas, Texas, United States
OLV Ziekenhuis Aalst
🇧🇪Aalst, Belgium
Allegiance Reserach Specialists, LLC
🇺🇸Wauwatosa, Wisconsin, United States
Joanne F. Liutkus Medicine Professional Corporation
🇨🇦Cambridge, Ontario, Canada
Canadian Phase Onward
🇨🇦Toronto, Ontario, Canada
PTC,Primary care Trial Center
🇸🇪Goteborg, Sweden
Dr. Anil K Gupta Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
Centrum Badań Klinicznych PI-House sp. z o.o.
🇵🇱Gdańsk, Poland
Katarina Berndtsson-Blom Ladulaaskliniken
🇸🇪Borås, Sweden
PharmaSite
🇸🇪Malmo, Sweden
Intern Medicin
🇸🇪Göteborg, Sweden
NZOZ 'Linia' Centrum Leczenia Zaburzeń Metabolicznych Magdalena Olszanecka-Glinianowicz
🇵🇱Katowice, Poland
Southmead Hospital
🇬🇧Bristol, United Kingdom
PTC- Skaraborg
🇸🇪Skövde, Sweden
Avdelningen för kliniska prövningar
🇸🇪Örebro, Sweden
Ashgate Medical Practice
🇬🇧Chesterfield, United Kingdom
Hathaway Medical Centre
🇬🇧Chippenham, United Kingdom
Clifton Medical Centre
🇬🇧Rotherham, United Kingdom
Aintree University Hospital NHS Trust
🇬🇧Liverpool, United Kingdom
Albany House Medical Centre
🇬🇧Wellingborough, United Kingdom
Bradford on Avon and Melksham Health Partnership
🇬🇧Wiltshire, United Kingdom