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

Registration Number
NCT03486392
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
474
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Double-Blind: JNJ-64565111 Dose Level 3JNJ-64565111 Dose Level 3Participants will receive a JNJ-64565111 Dose Level 3 SC once-weekly for 26-week treatment phase.
Double-Blind: JNJ-64565111 Dose Level 1JNJ-64565111 Dose Level 1Participants will receive a JNJ-64565111 Dose Level 1 subcutaneously (SC) once-weekly for 26-week treatment phase.
Double-Blind: JNJ-64565111 Dose Level 2JNJ-64565111 Dose Level 2Participants will receive a JNJ-64565111 Dose Level 2 SC once-weekly for 26-week treatment phase.
Double-Blind: PlaceboPlaceboParticipants will receive placebo matching to JNJ-64565111 SC once-weekly for 26-week treatment phase.
Open-Label: 3.0 milligram (mg) LiraglutideLiraglutideParticipant 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 Outcome Measures
NameTimeMethod
Percent Change From Baseline in Body Weight at Week 26Baseline, 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)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
NameTimeMethod
Change From Baseline in Body Weight at Week 26Baseline, Week 26

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

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

Number of participants with \>= 10 % body weight loss from baseline to Week 26 were reported.

Trial Locations

Locations (47)

CSL Arlon

🇧🇪

Arlon, Belgium

AZ Delta

🇧🇪

Roeselare, Belgium

Clinique des Maladies Lipidiques de Québec

🇨🇦

Québec, Quebec, Canada

Nzoz Salvia

🇵🇱

Katowice-Ligota, Poland

UZ Antwerpen

🇧🇪

Edegem, Belgium

Practimed Medical Center

🇧🇪

Tessenderlo, Belgium

Manna Research

🇨🇦

Pointe Claire, Quebec, Canada

Indywidualna Praktyka Lekarska, Gabinet Leczenia Otyłości i Chorób Dietozależnych

🇵🇱

Białystok, Poland

CHU de Liège

🇧🇪

Liège, Belgium

AZ Glorieux Ronse

🇧🇪

Ronse, Belgium

L-Marc Research Center

🇺🇸

Louisville, Kentucky, United States

Rapid Medical Research

🇺🇸

Cleveland, Ohio, United States

Omega Medical Research

🇺🇸

Warwick, Rhode Island, United States

Coastal Carolina Research Center

🇺🇸

Mount Pleasant, South Carolina, United States

UZ Leuven

🇧🇪

Leuven, Belgium

Centrum Zdrowia Metabolicznego Paweł Bogdański

🇵🇱

Poznan, Poland

Central Phoenix Medical Clinic

🇺🇸

Phoenix, Arizona, United States

Diablo Clinical Research, Inc.

🇺🇸

Walnut Creek, California, United States

Care Partners Clinical Research

🇺🇸

Jacksonville, Florida, United States

Advanced Clinical Research

🇺🇸

West Jordan, Utah, United States

Central New York Clinical Research

🇺🇸

Manlius, New York, United States

Milford Emergency Associates, Inc.

🇺🇸

Marlborough, Massachusetts, United States

Medisphere Medical Research Center, Llc

🇺🇸

Evansville, Indiana, United States

Rainier Clinical Research Center

🇺🇸

Renton, Washington, United States

Weill Cornell Medicine

🇺🇸

New York, New York, United States

Permian Research Foundation

🇺🇸

Odessa, Texas, United States

Dallas Diabetes Research Center

🇺🇸

Dallas, Texas, United States

OLV Ziekenhuis Aalst

🇧🇪

Aalst, Belgium

Allegiance Reserach Specialists, LLC

🇺🇸

Wauwatosa, Wisconsin, United States

Joanne F. Liutkus Medicine Professional Corporation

🇨🇦

Cambridge, Ontario, Canada

Canadian Phase Onward

🇨🇦

Toronto, Ontario, Canada

PTC,Primary care Trial Center

🇸🇪

Goteborg, Sweden

Dr. Anil K Gupta Medicine Professional Corporation

🇨🇦

Toronto, Ontario, Canada

Centrum Badań Klinicznych PI-House sp. z o.o.

🇵🇱

Gdańsk, Poland

Katarina Berndtsson-Blom Ladulaaskliniken

🇸🇪

Borås, Sweden

PharmaSite

🇸🇪

Malmo, Sweden

Intern Medicin

🇸🇪

Göteborg, Sweden

NZOZ 'Linia' Centrum Leczenia Zaburzeń Metabolicznych Magdalena Olszanecka-Glinianowicz

🇵🇱

Katowice, Poland

Southmead Hospital

🇬🇧

Bristol, United Kingdom

PTC- Skaraborg

🇸🇪

Skövde, Sweden

Avdelningen för kliniska prövningar

🇸🇪

Örebro, Sweden

Ashgate Medical Practice

🇬🇧

Chesterfield, United Kingdom

Hathaway Medical Centre

🇬🇧

Chippenham, United Kingdom

Clifton Medical Centre

🇬🇧

Rotherham, United Kingdom

Aintree University Hospital NHS Trust

🇬🇧

Liverpool, United Kingdom

Albany House Medical Centre

🇬🇧

Wellingborough, United Kingdom

Bradford on Avon and Melksham Health Partnership

🇬🇧

Wiltshire, United Kingdom

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