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

June 20, 2018 updated by: Ionis Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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

  2. 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)
  3. Body Mass Index (BMI) between 30.0 and 40.0 kg/m2, inclusive
  4. Patients who are willing to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures
  5. Agree to abstain from alcoholic beverages for at least 48 hours prior to clinic visits
  6. Agree to maintain current diet and exercise regimen from Screening until End-of-Study

Exclusion Criteria:

  1. 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
  2. Positive test for HIV, hepatitis B or C at Screening
  3. Hypothyroidism or Hyperthyroidism
  4. Weight change > 5% in the 3 months prior to Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered subcutaneously
Drug: Placebo
Placebo administered subcutaneously
Experimental: ISIS-FGFR4RX
ISIS-FGFR4RX administered subcutaneously
Drug: ISIS-FGFR4RX
ISIS-FGFR4RX administered subcutaneously
Other Names:
  • ISIS 463588

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From baseline to the average of weeks 14 and 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability will be assessed by determining the incidence, and severity of adverse effects and changes in laboratory evaluations within each treatment group.
Time Frame: 33 weeks
Safety results in patients dosed with ISIS 463588 will be compared with those from patients dosed with placebo
33 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 19, 2015

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 463588-CS2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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