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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT03486392 (opens ClinicalTrials.gov in a new tab)Other idCR108314Other id64565111OBE2001Other id2017-003616-39Other id2017
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
474 participants (actual)
Sponsor
Janssen Research & Development, LLC · Industry
Design
Randomized · Double masking
Countries
6 countries

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

Start
26 Mar 2018
Primary completion
8 Mar 2019
Completion
8 Mar 2019
First posted
3 Apr 2018
Last update posted
5 Feb 2020
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 2

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

    NCT03486392

    26 Mar 2018 to 8 Mar 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • JNJ-64565111 Dose Level 1Drug
  • JNJ-64565111 Dose Level 2Drug
  • JNJ-64565111 Dose Level 3Drug
  • LiraglutideDrug
  • PlaceboDrug

Arms5

  • 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 outcomes2

Outcomes the sponsor listed as primary.

  1. Percent Change From Baseline in Body Weight at Week 26

    Time frame · Baseline, Week 26

    Registry description

    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

    Registry description

    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 outcomes(3)

  1. Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26

    Time frame · Week 26

    Registry description

    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

    Registry description

    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

    Registry description

    Change from baseline in body weight at Week 26 was reported.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 26

Percent Change From Baseline in Body Weight at Week 26

GroupValue (Percent Change)Spread
Double Blind: Placebo-1.760.73
Double Blind: JNJ-64565111 5.0 mg-8.510.76
Double Blind: JNJ-64565111 7.4 mg-9.830.56
Double Blind: JNJ-64565111 10.0 mg-11.800.58
Open Label: Liraglutide 3.0 mg-7.540.54
Primary outcomeCount of participants· Up to Week 30

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

GroupValue (Participants)
Double Blind: Placebo43
Double Blind: JNJ-64565111 5.0 mg53
Double Blind: JNJ-64565111 7.4 mg110
Double Blind: JNJ-64565111 10.0 mg110
Open Label: Liraglutide 3.0 mg96
Secondary and other outcome results(3)
Secondary outcomeCount of participants· Week 26

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

GroupValue (Participants)
Double Blind: Placebo8
Double Blind: JNJ-64565111 5.0 mg34
Double Blind: JNJ-64565111 7.4 mg70
Double Blind: JNJ-64565111 10.0 mg62
Open Label: Liraglutide 3.0 mg56
Secondary outcomeCount of participants· Week 26

Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26

GroupValue (Participants)
Double Blind: Placebo2
Double Blind: JNJ-64565111 5.0 mg23
Double Blind: JNJ-64565111 7.4 mg43
Double Blind: JNJ-64565111 10.0 mg46
Open Label: Liraglutide 3.0 mg27
Secondary outcomeLeast squares mean· Baseline, Week 26

Change From Baseline in Body Weight at Week 26

GroupValue (kg)Spread
Double Blind: Placebo-2.050.827
Double Blind: JNJ-64565111 5.0 mg-9.580.861
Double Blind: JNJ-64565111 7.4 mg-11.070.633
Double Blind: JNJ-64565111 10.0 mg-13.230.656
Open Label: Liraglutide 3.0 mg-8.320.610

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Double Blind: PlaceboParticipants self-administered the matching placebo of JNJ-64565111 subcutaneously (SC) once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.0 / 604 / 6033 / 60
Double Blind: JNJ-64565111 5.0 mgParticipants self-administered 5.0 milligram (mg) JNJ-64565111 SC once weekly throughout the 26-week treatment phase or until early discontinuation of study drug.0 / 593 / 5943 / 59
Double Blind: JNJ-64565111 7.4 mgParticipants self-administered 7.4 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.0 / 1182 / 118106 / 118
Double Blind: JNJ-64565111 10.0 mgParticipants self-administered 10.0 mg JNJ-64565111 SC once-weekly throughout the 26-week treatment phase or until early discontinuation of study drug.0 / 1184 / 118104 / 118
Open Label: Liraglutide 3.0 mgParticipant self-administered liraglutide at a starting dose of 0.6 mg SC once-daily on Day 1, followed by dose titration up to 1.2, 1.8, 2.4, and 3.0 mg in Weeks 2, 3, 4, and 5 (with 0.6 mg weekly increment up to the full dosage of 3.0 mg by Week 5). Participants then continued the 3.0 mg once-daily dosage until Week 26 or until early drug discontinuation.1 / 1194 / 11981 / 119

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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