Skip to main content
OpenTrials
Completed

NCT Number: NCT03486392

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

OLV Ziekenhuis Aalst, Aalst, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-64565111 Dose Level 1

Drug

Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.

JNJ-64565111 Dose Level 2

Drug

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

JNJ-64565111 Dose Level 3

Drug

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

liraglutide

Drug

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 names: Saxenda

Placebo

Drug

Participants will receive matching placebo SC once-weekly until Week 26.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 3, 2018
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.