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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

Tracking Information
First Submitted Date  ICMJE March 23, 2018
First Posted Date  ICMJE April 3, 2018
Results First Submitted Date  ICMJE January 14, 2020
Results First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE March 26, 2018
Actual Primary Completion Date March 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
  • Percent Change in Body Weight from Baseline to Week 26 Compared to Placebo [ Time Frame: Baseline up to Week 26 ]
    The percent change in body weight will be assessed.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to Week 33 ]
    An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2018)
  • Percentage of Participants with Greater Than or Equal to (>=) 5% Weight Loss from Baseline to Week 26 Compared to Placebo [ Time Frame: Baseline up to Week 26 ]
    Percentage of participants with >= 5 percent (%) weight loss will be reported.
  • Percentage of Participants with >= 10% Weight Loss from Baseline to Week 26 Compared to Placebo [ Time Frame: Baseline up to Week 26 ]
    Percentage of participants with >= 10% weight loss will be reported.
  • Change in Body Weight from Baseline at Week 26 Compared to Placebo [ Time Frame: Baseline up to Week 26 ]
    Change in body weight will be assessed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: JNJ-64565111 Dose Level 1
    Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
  • Drug: JNJ-64565111 Dose Level 2
    Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
  • Drug: JNJ-64565111 Dose Level 3
    Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly 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
  • Drug: Placebo
    Participants will receive matching placebo SC once-weekly until Week 26.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: JNJ-64565111 Dose Level 1
  • 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.
    Intervention: Drug: JNJ-64565111 Dose Level 2
  • 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.
    Intervention: Drug: JNJ-64565111 Dose Level 3
  • Placebo Comparator: Double-Blind: Placebo
    Participants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Liraglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2020)
474
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2018)
440
Actual Study Completion Date  ICMJE March 8, 2019
Actual Primary Completion Date March 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Poland,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03486392
Other Study ID Numbers  ICMJE CR108314
64565111OBE2001 ( Other Identifier: Janssen Research & Development, LLC )
2017-003616-39 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP