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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03486392
• Other study ID #: CR108314
• Secondary ID: 64565111OBE20012
• Status: Completed
• Phase: Phase 2
• Start date: March 26, 2018
• Est. completion date: March 8, 2019

Study information

• Verified date: January 2020
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 474
• Est. completion date: March 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• JNJ-64565111 Dose Level 1
Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
• JNJ-64565111 Dose Level 2
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
• JNJ-64565111 Dose Level 3
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
• 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.
• Placebo
Participants will receive matching placebo SC once-weekly until Week 26.

Locations

Country	Name	City	State
Belgium	OLV Ziekenhuis Aalst	Aalst
Belgium	CSL Arlon	Arlon
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Leuven	Leuven
Belgium	CHU de Liège	Liège
Belgium	AZ Delta	Roeselare
Belgium	AZ Glorieux Ronse	Ronse
Belgium	Practimed Medical Center	Tessenderlo
Canada	Joanne F. Liutkus Medicine Professional Corporation	Cambridge	Ontario
Canada	Manna Research	Levis	Quebec
Canada	Manna Research	Pointe Claire	Quebec
Canada	Clinique des Maladies Lipidiques de Québec	Québec	Quebec
Canada	Canadian Phase Onward	Toronto	Ontario
Canada	Dr. Anil K Gupta Medicine Professional Corporation	Toronto	Ontario
Canada	Manna Research	Toronto	Ontario
Poland	Indywidualna Praktyka Lekarska, Gabinet Leczenia Otylosci i Chorób Dietozaleznych	Bialystok
Poland	Centrum Badan Klinicznych PI-House sp. z o.o.	Gdansk
Poland	NZOZ 'Linia' Centrum Leczenia Zaburzen Metabolicznych Magdalena Olszanecka-Glinianowicz	Katowice
Poland	Nzoz Salvia	Katowice-Ligota
Poland	Centrum Zdrowia Metabolicznego Pawel Bogdanski	Poznan
Sweden	Katarina Berndtsson-Blom Ladulaaskliniken	Borås
Sweden	PTC,Primary care Trial Center	Goteborg
Sweden	Intern Medicin	Göteborg
Sweden	PharmaSite	Helsingborg
Sweden	PharmaSite	Malmo
Sweden	Avdelningen för kliniska prövningar	Örebro
Sweden	PTC- Skaraborg	Skövde
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Ashgate Medical Practice	Chesterfield
United Kingdom	Hathaway Medical Centre	Chippenham
United Kingdom	Aintree University Hospital NHS Trust	Liverpool
United Kingdom	Clifton Medical Centre	Rotherham
United Kingdom	Albany House Medical Centre	Wellingborough
United Kingdom	Bradford on Avon and Melksham Health Partnership	Wiltshire
United States	Advanced Clinical Research	Boise	Idaho
United States	Rapid Medical Research	Cleveland	Ohio
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Medisphere Medical Research Center, Llc	Evansville	Indiana
United States	Care Partners Clinical Research	Jacksonville	Florida
United States	L-Marc Research Center	Louisville	Kentucky
United States	Central New York Clinical Research	Manlius	New York
United States	Milford Emergency Associates, Inc.	Marlborough	Massachusetts
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Weill Cornell Medicine	New York	New York
United States	Permian Research Foundation	Odessa	Texas
United States	Central Phoenix Medical Clinic	Phoenix	Arizona
United States	Rainier Clinical Research Center	Renton	Washington
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Omega Medical Research	Warwick	Rhode Island
United States	Allegiance Reserach Specialists, LLC	Wauwatosa	Wisconsin
United States	Advanced Clinical Research	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Body Weight at Week 26	Percent change in body weight in kilograms (kg) from baseline to Week 26 was reported.	Baseline, Week 26
Primary	Number of Participants With Treatment Emergent Adverse Events (TEAEs)	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.	Up to Week 30
Secondary	Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26	Number of participants with >= 5% body weight loss from baseline to Week 26 were reported.	Week 26
Secondary	Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26	Number of participants with >= 10 % body weight loss from baseline to Week 26 were reported.	Week 26
Secondary	Change From Baseline in Body Weight at Week 26	Change from baseline in body weight at Week 26 was reported.	Baseline, Week 26