JNJ-64565111, Placebo, Liraglutide in Severely Obese, Non-diabetics
Research type
Research Study
Full 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
IRAS ID
236137
Contact name
Nick Hodges
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2017-003616-39
Duration of Study in the UK
0 years, 10 months, 5 days
Research summary
This is a study in non-diabetic, severely obese adults. Prevalence of obesity is increasing worldwide; affecting more than 650 million adults. It is estimated that worldwide obesity has nearly tripled since 1975. There is a need for better weight-management therapies that enable patients to achieve a meaningful weight loss and that may also positively affect obesity-related conditions.
The purpose of this study is to determine if JNJ-64565111 is useful for treating patients with obesity and compare the effects of JNJ-64565111 to those of liraglutide and/or placebo. Liraglutide is a drug already used to treat obesity. JNJ-64565111, placebo and liraglutide are given via injection at regular time points throughout the study (JNJ-64565111 and placebo will be injected weekly and liraglutide will be injected daily). The safety of JNJ-64565111 will be studied. The study will also look to find the dose of JNJ-64565111 that would be best to use in future studies for the treatment of obesity. The effects on obesity as well as any side effects will be explored.
The study is divided into 3 parts over 33 weeks: Screening - this must be completed 3 weeks before taking the study drug and will include different tests (e.g. blood pressure, blood tests, physical examination) to determine if participants are eligible to take part and will also include a 2-week injection training period for participants. Treatment - if eligible, participants will be randomly assigned (like flipping a coin) to JNJ-64565111, placebo or liraglutide and will be required to attend the study clinic on a regular basis over a 26-week period. Post-Treatment Follow-up - participants will return to the study clinic 4 or 5 weeks after the last dose of study drug to collect safety information.
REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0241
Date of REC Opinion
30 Apr 2018
REC opinion
Favourable Opinion