Study S002303

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

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03486392
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 474
Start: 2018-03-26
Primary completion: 2019-03-08
Lead sponsor: Janssen Research & Development, LLC
Conditions: Obesity
Interventions: DRUG:JNJ-64565111 Dose Level 1; DRUG:JNJ-64565111 Dose Level 2; DRUG:JNJ-64565111 Dose Level 3; DRUG:Liraglutide; DRUG:Placebo
Results posted: TRUE
Secondary identifiers: OTHER:64565111OBE2001; EUDRACT_NUMBER:2017-003616-39; NIH:2017

Registered primary outcomes

Percent Change From Baseline in Body Weight at Week 26 [Baseline, Week 26]
Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Up to Week 30]

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