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A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Participants With Type 2 Diabetes Mellitus

NCT03586830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2020-01-07

Study results available
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Summary

The purpose of this study is to assess the effects of JNJ-64565111 compared with placebo in severely obese Type 2 Diabetes Mellitus (T2DM) participants after 12 weeks of treatment on: the percentage change in body weight from baseline and safety and tolerability.

Conditions

  • Obesity and Diabetes Mellitus, Type 2

Interventions

DRUG

JNJ-64565111 Dose Level 1

Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.

DRUG

JNJ-64565111 Dose Level 2

Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.

DRUG

JNJ-64565111 Dose Level 3

Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.

DRUG

Placebo

Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-26
Primary Completion
2019-04-05
Completion
2019-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03586830 on ClinicalTrials.gov