A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Obesity
In brief
The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX.
Key facts
- Study ID
- NCT02476019
- Run by
- Ionis Pharmaceuticals, Inc.
- People needed
- 13
- Starts
- 2015-06-01
- Expected to finish
- 2016-09-01
- Last updated by the study team
- 2018-06-25
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Translational Research Institute for Metabolism and Diabetes — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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