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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486392
Recruitment Status : Completed
First Posted : April 3, 2018
Results First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: JNJ-64565111 Dose Level 1 Drug: JNJ-64565111 Dose Level 2 Drug: JNJ-64565111 Dose Level 3 Drug: Liraglutide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 474 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 26, 2018
Actual Primary Completion Date : March 8, 2019
Actual Study Completion Date : March 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
Drug Information available for: Liraglutide

Arm Intervention/treatment
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.
Drug: JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.

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.
Drug: JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.

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.
Drug: JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.

Placebo Comparator: Double-Blind: Placebo
Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.
Drug: Placebo
Participants will receive matching placebo SC once-weekly until Week 26.

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.
Drug: Liraglutide
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.
Other Name: Saxenda




Primary Outcome Measures :
  1. Percent Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline, Week 26 ]
    Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.

  2. Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 30 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A TEAE was defined as an AE with an onset after the initiation study drug and before the last study drug date of the double-blind (26-week) treatment phase for plus 28 days for liraglutide participants, and plus 35 days for JNJ-64565111 and placebo participants.


Secondary Outcome Measures :
  1. Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26 [ Time Frame: Week 26 ]
    Number of participants with >= 5% body weight loss from baseline to Week 26 were reported.

  2. Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26 [ Time Frame: Week 26 ]
    Number of participants with >= 10 % body weight loss from baseline to Week 26 were reported.

  3. Change From Baseline in Body Weight at Week 26 [ Time Frame: Baseline, Week 26 ]
    Change from baseline in body weight at Week 26 was reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486392


Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] August 23, 2018
Statistical Analysis Plan  [PDF] March 26, 2019

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03486392    
Other Study ID Numbers: CR108314
64565111OBE2001 ( Other Identifier: Janssen Research & Development, LLC )
2017-003616-39 ( EudraCT Number )
First Posted: April 3, 2018    Key Record Dates
Results First Posted: February 5, 2020
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists