A Double Blind, Randomized, Placebo-controlled, Single Center, Phase 2a Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 463588 (ISIS-FGFR4RX, an Antisense Inhibitor of Fibroblast Growth Factor Receptor 4) Administered Subcutaneously Once Weekly for 13 Weeks in Obese Patients

Ionis Pharmaceuticals, Inc.1 site in 1 country13 target enrollmentJune 2015

ConditionsObesity

InterventionsISIS-FGFR4RX Placebo

DrugsISIS-FGFR4RX Placebo

Overview

Phase: Phase 2
Intervention: ISIS-FGFR4RX
Conditions: Obesity
Sponsor: Ionis Pharmaceuticals, Inc.
Enrollment: 13
Locations: 1
Primary Endpoint: Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

September 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ionis Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements
•Male or female patients between the age of 18-65 years, inclusive
•Females: Must be post-menopausal (defined as 12 months of spontaneous amenorrhea in females \> 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved)
•Males: Surgically sterile, abstinent or if engaged in sexual relations with women of childbearing potential, patient is utilizing an acceptable contraceptive method during and for 5 months after the last dose of ISIS 463588 or placebo (Study Drug)
•Body Mass Index (BMI) between 30.0 and 40.0 kg/m2, inclusive
•Patients who are willing to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures
•Agree to abstain from alcoholic beverages for at least 48 hours prior to clinic visits
•Agree to maintain current diet and exercise regimen from Screening until End-of-Study

Exclusion Criteria

•Clinically significant abnormalities in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening) or physical examination
•Positive test for HIV, hepatitis B or C at Screening
•Hypothyroidism or Hyperthyroidism
•Weight change \> 5% in the 3 months prior to Screening

Arms & Interventions

ISIS-FGFR4RX

ISIS-FGFR4RX administered subcutaneously

Intervention: ISIS-FGFR4RX

Placebo

Placebo administered subcutaneously

Intervention: Placebo

Outcomes

Primary Outcomes

Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry

Time Frame: From baseline to the average of weeks 14 and 16

As measured by: * Resting Metabolic rate (kcal/min) * Resting metabolic rate adjusted for changes in body composition (kcal/min) * Resting fat oxidation (grams/24 hr)

Secondary Outcomes

Safety and Tolerability will be assessed by determining the incidence, and severity of adverse effects and changes in laboratory evaluations within each treatment group.(33 weeks)