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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03486392
• Date of registration: 23/03/2018
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
• Scientific 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
• Date of first enrolment: March 26, 2018
• Target sample size: 474
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03486392
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

Belgium, Canada, Poland, Sweden, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Intervention(s)

Drug: Liraglutide

Drug: JNJ-64565111 Dose Level 1

Drug: JNJ-64565111 Dose Level 2

Drug: JNJ-64565111 Dose Level 3

Drug: Placebo

Primary Outcome(s)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to Week 30]

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

Secondary Outcome(s)

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

Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26 [Time Frame: Week 26]

Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26 [Time Frame: Week 26]

Secondary ID(s)

64565111OBE2001

2017-003616-39

CR108314

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/02/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03486392