Back to results

A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients (FGFR4-CS2)

Primary Purpose

Obesity

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ISIS-FGFR4RX

Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Energy Expenditure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Translational Research Institute for Metabolism and Diabetes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ISIS-FGFR4RX

Placebo

Arm Description

ISIS-FGFR4RX administered subcutaneously

Placebo administered subcutaneously

Outcomes

Primary Outcome Measures

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

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 Outcome Measures

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

Safety results in patients dosed with ISIS 463588 will be compared with those from patients dosed with placebo

Full Information

NCT ID

NCT02476019

First Posted

June 15, 2015

Last Updated

June 20, 2018

Sponsor

Ionis Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02476019

Brief Title

A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients

Acronym

FGFR4-CS2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

July 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ionis Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Energy Expenditure

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ISIS-FGFR4RX

Arm Type

Experimental

Arm Description

ISIS-FGFR4RX administered subcutaneously

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered subcutaneously

Intervention Type

Drug

Intervention Name(s)

ISIS-FGFR4RX

Other Intervention Name(s)

ISIS 463588

Intervention Description

ISIS-FGFR4RX administered subcutaneously

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo administered subcutaneously

Primary Outcome Measure Information:

Title

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

Description

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)

Time Frame

From baseline to the average of weeks 14 and 16

Secondary Outcome Measure Information:

Title

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

Description

Safety results in patients dosed with ISIS 463588 will be compared with those from patients dosed with placebo

Time Frame

33 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Translational Research Institute for Metabolism and Diabetes

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients

We'll reach out to this number within 24 hrs