A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• JNJ-64565111 Dose Level 1 — DRUG
  Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
• JNJ-64565111 Dose Level 2 — DRUG
  Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
• JNJ-64565111 Dose Level 3 — DRUG
  Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
• Liraglutide — DRUG
  Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.
• Placebo — DRUG
  Participants will receive matching placebo SC once-weekly until Week 26.

Study Details

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.

Key Dates

Start date

Mar 26, 2018

Status verified

Jan 2020

Primary completion

Mar 8, 2019

Completion

Mar 8, 2019

Study Design

Enrollment

474 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Double-Blind: JNJ-64565111 Dose Level 1
  Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.
• Experimental: Double-Blind: JNJ-64565111 Dose Level 2
  Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.
• Experimental: Double-Blind: JNJ-64565111 Dose Level 3
  Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.
• Placebo Comparator: Double-Blind: Placebo
  Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.
• Active Comparator: Open-Label: 3.0 milligram (mg) 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 Measure

Percent Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline, Week 26 ]

Locations (17)

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