Recent Updates
Recently added Catalysts

R256918

Phase 2

Obesity | Small molecule | Metabolic |Johnson & Johnson|Last Updated: May 13, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment392

FDA Designations

No designations recorded

Clinical trial landscape

R256918 · 2 trials · 5 indications

Phase 2 2
NCT01041677A Study of the Safety of R256918 in Obese PatientsObesity
COMPLETED71 Analytics
NCT00622765A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese PatientsObesity
COMPLETED321 Analytics
PHASE2COMPLETED
A Study of the Safety of R256918 in Obese Patients
ObesityUnlock trial analytics
PHASE2COMPLETED
A Study of the Safety and Effectiveness of JNJ-16269110 (R256918) in Overweight and Obese Patients
ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Hepatic Triglyceride Content (HTGC) as measured by 1H-Magnetic Resonance Spectroscopy (MRS).
Baseline, 6 weeks, 12 weeks
Mean change in body weight from baseline to Week 12.
Baseline, 12 weeks

Secondary Endpoints

Change in Body weight
Baseline, weeks 1, 2, 4, 6, 8,10,12,14
Change in alanine aminotransferase and aspartate aminotransferase
Baseline, weeks 4, 6, 8,12,14
Changes in fasting glucose and insulin
Baseline, weeks 6, 12
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
001EXPERIMENTALR256918 10 mg capsule twice daily
002EXPERIMENTALR256918 15 mg capsule twice daily
003PLACEBO_COMPARATORplacebo placebo capsule twice daily
004PLACEBO_COMPARATORplacebo Placebo capsule twice daily

Interventions

NameTypeDescription
R256918DRUG10 mg capsule twice daily
placeboDRUGplacebo capsule twice daily
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Liver fat content (HTGC) between 3% and 15% * Obese defined as BMI between 30 and 50 kg/square meter * Fasting plasma glucose \< 7.0 mmol/liter Exclusion Criteria: * History of Obesity with a known cause (eg. Cushings disease) * Diabetes Mellitus * Weight reducing diet or re...

Countries:FinlandNetherlandsSwedenBelgiumDenmarkGermanyUnited Kingdom
Unlock Eligibility Criteria

Frequently asked questions about R256918

What is R256918 used for?

R256918 is an investigational small molecule being developed for obesity. It is being studied in overweight and obese patients as part of a clinical development program. The drug is not approved and remains in clinical trials.

Who makes R256918?

R256918 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in patients with obesity.

What phase is R256918 in?

R256918 is in Phase 2 clinical development. Two Phase 2 trials have been completed, with a total of 392 participants enrolled. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is R256918 in?

R256918 has been studied in two completed Phase 2 trials. NCT00622765 enrolled 321 overweight and obese patients across seven European countries, and NCT01041677 enrolled 71 obese patients in Finland, the Netherlands, and Sweden. Both trials were randomized, double-blind, and placebo-controlled.

Is R256918 the same as JNJ-16269110?

Yes, R256918 is also known as JNJ-16269110. The first clinical trial, NCT00622765, used the name JNJ-16269110 in its title, while the second trial, NCT01041677, used R256918. Both names refer to the same investigational drug for obesity.