Study S003205

A Randomized, Double-blind Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Subjects With Type 2 Diabetes Mellitus

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

Registration

Registration: NCT03586830
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 196
Start: 2018-06-26
Primary completion: 2019-04-05
Lead sponsor: Janssen Research & Development, LLC
Conditions: Obesity and Diabetes Mellitus, Type 2
Interventions: DRUG:JNJ-64565111 Dose Level 1; DRUG:JNJ-64565111 Dose Level 2; DRUG:JNJ-64565111 Dose Level 3; DRUG:Placebo
Results posted: TRUE
Secondary identifiers: OTHER:64565111OBE2002

Registered primary outcomes

Percent Change From Baseline in Body Weight at Week 12 [Baseline, Week 12]
Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Up to 16 Weeks]

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