Clinical trial NCT03486392: A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2018-04-03
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Body Weight at Week 26
timeFrame: Baseline, Week 26
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 30
Secondary outcomes:
measure: Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26
timeFrame: Week 26
measure: Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26
timeFrame: Week 26
measure: Change From Baseline in Body Weight at Week 26
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Jacksonville
country: United States
facility: Care Partners Clinical Research
state: Florida
city: Boise
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Evansville
country: United States
facility: Medisphere Medical Research Center, Llc
state: Indiana
city: Louisville
country: United States
facility: L-Marc Research Center
state: Kentucky
city: Marlborough
country: United States
facility: Milford Emergency Associates, Inc.
state: Massachusetts
city: Manlius
country: United States
facility: Central New York Clinical Research
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Odessa
country: United States
facility: Permian Research Foundation
state: Texas
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Wauwatosa
country: United States
facility: Allegiance Reserach Specialists, LLC
state: Wisconsin
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Arlon
country: Belgium
facility: CSL Arlon
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHU de Liège
city: Roeselare
country: Belgium
facility: AZ Delta
city: Ronse
country: Belgium
facility: AZ Glorieux Ronse
city: Tessenderlo
country: Belgium
facility: Practimed Medical Center
city: Cambridge
country: Canada
facility: Joanne F. Liutkus Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward
state: Ontario
city: Toronto
country: Canada
facility: Dr. Anil K Gupta Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Manna Research
state: Ontario
city: Levis
country: Canada
facility: Manna Research
state: Quebec
city: Pointe Claire
country: Canada
facility: Manna Research
state: Quebec
city: Québec
country: Canada
facility: Clinique des Maladies Lipidiques de Québec
state: Quebec
city: Białystok
country: Poland
facility: Indywidualna Praktyka Lekarska, Gabinet Leczenia Otyłości i Chorób Dietozależnych
city: Gdańsk
country: Poland
facility: Centrum Badań Klinicznych PI-House sp. z o.o.
city: Katowice-Ligota
country: Poland
facility: Nzoz Salvia
city: Katowice
country: Poland
facility: NZOZ 'Linia' Centrum Leczenia Zaburzeń Metabolicznych Magdalena Olszanecka-Glinianowicz
city: Poznan
country: Poland
facility: Centrum Zdrowia Metabolicznego Paweł Bogdański
city: Borås
country: Sweden
facility: Katarina Berndtsson-Blom Ladulaaskliniken
city: Goteborg
country: Sweden
facility: PTC,Primary care Trial Center
city: Göteborg
country: Sweden
facility: Intern Medicin
city: Helsingborg
country: Sweden
facility: PharmaSite
city: Malmo
country: Sweden
facility: PharmaSite
city: Skövde
country: Sweden
facility: PTC- Skaraborg
city: Örebro
country: Sweden
facility: Avdelningen för kliniska prövningar
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Chesterfield
country: United Kingdom
facility: Ashgate Medical Practice
city: Chippenham
country: United Kingdom
facility: Hathaway Medical Centre
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital NHS Trust
city: Rotherham
country: United Kingdom
facility: Clifton Medical Centre
city: Wellingborough
country: United Kingdom
facility: Albany House Medical Centre
city: Wiltshire
country: United Kingdom
facility: Bradford on Avon and Melksham Health Partnership
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: