Obesity
Conditions
Keywords
Obesity, Energy Expenditure
Brief summary
The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX.
Interventions
DRUGISIS-FGFR4RX
ISIS-FGFR4RX administered subcutaneously
DRUGPlacebo
Placebo administered subcutaneously
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Safety results in patients dosed with ISIS 463588 will be compared with those from patients dosed with placebo |
Countries
United States
Outcome results
None listed