JNJ-64565111 Dose Level 1
DrugParticipants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
NCT Number: NCT03586830
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 2
Central Research Associates, Inc., Birmingham, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.
Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.
Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.
Time frame: Baseline, Week 12
Percent change from baseline in body weight in kilograms (kg) at Week 12 was reported.
Time frame: Up to 16 Weeks
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. An TEAE is defined as an AE with an onset after the initiation study medication and before the last study medication date of the double-blind (12-Week) treatment phase plus 35 Days.
Time frame: Baseline, Week 12
Change from baseline in body weight at Week 12 was reported.
Time frame: Week 12
Number of participants with >= 5 % weight loss at Week 12 was reported.
Janssen Research & Development, LLC
Industry
A Randomized, Double-blind Placebo-controlled, Parallel-group, Multicenter, Dose-ranging Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Severely Obese Subjects With Type 2 Diabetes Mellitus
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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