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

Phase 1

• Conditions: Obesity; MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2017-003616-39-PL
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 440

Inclusion Criteria

1. Male or female
2. 18 to 70 years of age, inclusive
3. BMI = 35 to = 50 kg/m2 at the screening visit
4. Stable weight (ie, change of = 5% within 12 weeks before screening based on medical history)
5. Subjects must have 100% compliance with the open-label placebo run-in medication
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1. History of Type 1 or Type II Diabetes mellitus
2. Screening calcitonin of = 50 pg/mL (= 50 ng/L)
3. A myocardial infarction (MI), unstable angina, revascularization procedure, or cerebrovascular accident within 12 weeks before screening
4. Heart failure of New York Heart Association (NYHA) Class II-IV cardiac disease
5. History of acute or chronic pancreatitis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified