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

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