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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003616-39-BE

Enrollment

440

Registered

2018-03-15

Start date

2018-05-04

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Product Name: JNJ-64565111 Pharmaceutical Form: Solution for injection in pre-filled injector INN or Proposed INN: Not Available Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of JNJ-64565111. To assess the percentage change in body weight from baseline of JNJ-64565111 compared with placebo after 26 weeks of treatment. ; Secondary Objective: To assess the proportion of subjects with = 5% weight loss from baseline To assess the proportion of subjects with = 10% weight loss from baseline To assess the absolute change in body weight from baseline ;Primary end point(s): The primary efficacy endpoint will be the percentage change in body weight between JNJ-64565111 and placebo from baseline to Week 26.;Timepoint(s) of evaluation of this end point: 26 weeks	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of JNJ-64565111. To assess the percentage change in body weight from baseline of JNJ-64565111 compared with placebo after 26 weeks of treatment. ; Secondary Objective: To assess the proportion of subjects with = 5% weight loss from baseline To assess the proportion of subjects with = 10% weight loss from baseline To assess the absolute change in body weight from baseline ;Primary end point(s): The primary efficacy endpoint will be the percentage change in body weight between JNJ-64565111 and placebo from baseline to Week 26.;Timepoint(s) of evaluation of this end point: 26 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy analyses at Week 26 will include proportion of subjects with = 5% weight loss, proportion of subjects with = 10% weight loss, and the absolute change in body weight from baseline.;Timepoint(s) of evaluation of this end point: 26 weeks	—

Countries

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

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV

ClinicalTrialsEU@its.jnj.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026