Phase 2
N=474
A Study to Evaluate the Safety and Efficacy of JNJ-64565111 in Non-diabetic Severely Obese Participants
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT03486392 ↗Enrolled (actual)
474
Serious AEs
3.6%
Results posted
Feb 2020
Primary outcome: Primary: Percent Change From Baseline in Body Weight at Week 26 — -1.76; -8.51; -9.83; -11.80 Percent Change — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-64565111 Dose Level 1 (Drug); JNJ-64565111 Dose Level 2 (Drug); JNJ-64565111 Dose Level 3 (Drug); Liraglutide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Body Weight at Week 26 |
-1.76; -8.51; -9.83; -11.80; -7.54 | < 0.001 sig |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
43; 53; 110; 110; 96 | — |
| SECONDARY Number of Participants With Greater Than or Equal to (>=) 5 Percent (%) Body Weight Loss at Week 26 |
8; 34; 70; 62; 56 | — |
| SECONDARY Number of Participants With Greater Than or Equal to 10 % Body Weight Loss at Week 26 |
2; 23; 43; 46; 27 | — |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
-2.05; -9.58; -11.07; -13.23; -8.32 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) greater than or equal to (>=) 35 to less than or equal to ( = 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
Data sourced from ClinicalTrials.gov (NCT03486392). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.