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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 2

Conditions: Obesity

Treatments: Drug: JNJ-64565111 Dose Level 1; Drug: Placebo; Drug: JNJ-64565111 Dose Level 2; Drug: JNJ-64565111 Dose Level 3; Drug: Liraglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03486392

CR108314

64565111OBE2001 (Other Identifier)

2017-003616-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 474 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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474 participants in 5 patient groups, including a placebo group

Double-Blind: JNJ-64565111 Dose Level 1

Experimental group

Description:

Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.

Treatment:

Drug: JNJ-64565111 Dose Level 1

Double-Blind: JNJ-64565111 Dose Level 2

Experimental group

Description:

Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.

Treatment:

Drug: JNJ-64565111 Dose Level 2

Double-Blind: JNJ-64565111 Dose Level 3

Experimental group

Description:

Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.

Treatment:

Drug: JNJ-64565111 Dose Level 3

Double-Blind: Placebo

Placebo Comparator group

Description:

Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.

Treatment:

Drug: Placebo

Open-Label: 3.0 milligram (mg) Liraglutide

Active Comparator group

Description:

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.

Treatment:

Drug: Liraglutide