A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients
NCT ID: NCT02476019
Last Updated: 2018-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
13 participants
INTERVENTIONAL
2015-06-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ISIS-FGFR4RX
ISIS-FGFR4RX administered subcutaneously
ISIS-FGFR4RX
ISIS-FGFR4RX administered subcutaneously
Placebo
Placebo administered subcutaneously
Placebo
Placebo administered subcutaneously
Interventions
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ISIS-FGFR4RX
ISIS-FGFR4RX administered subcutaneously
Placebo
Placebo administered subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, United States
Countries
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Other Identifiers
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ISIS 463588-CS2
Identifier Type: -
Identifier Source: org_study_id
NCT02463240
Identifier Type: -
Identifier Source: nct_alias
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