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

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ClinicalTrials.gov Identifier: NCT02476019
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Obesity Drug: ISIS-FGFR4RX Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
Experimental: ISIS-FGFR4RX
ISIS-FGFR4RX administered subcutaneously
Drug: ISIS-FGFR4RX
ISIS-FGFR4RX administered subcutaneously
Other Name: ISIS 463588

Placebo Comparator: Placebo
Placebo administered subcutaneously
Drug: Placebo
Placebo administered subcutaneously




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476019


Locations
United States, Florida
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.

Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02476019     History of Changes
Obsolete Identifiers: NCT02463240
Other Study ID Numbers: ISIS 463588-CS2
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 25, 2018
Last Verified: June 2018

Keywords provided by Ionis Pharmaceuticals, Inc.:
Obesity
Energy Expenditure