Phase 2 Completed N=474 Randomized Double-blind Treatment

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

Obesity

Source: ClinicalTrials.gov NCT03486392 ↗

Enrolled (actual)

474

Serious AEs

3.6%

Results posted

Feb 2020

Primary outcomePrimary: Percent Change From Baseline in Body Weight at Week 26 — -1.76; -8.51; -9.83; -11.80 Percent Change — p=< 0.001

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.

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	—

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

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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. Informational only — not medical advice.