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

Phase 2

Completed

• Conditions: Obesity
• Interventions: Drug: ISIS-FGFR4RX; Drug: Placebo

• Registration Number: NCT02476019
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-19
• Primary Completion: 2016-07
• Study Completion: 2016-09
• Status Verified: 2018-06
• Disposition First Submitted: 2018-06-20
• Disposition First Submitted QC: 2018-06-20
• Last Update Submitted: 2018-06-20
• Disposition First Posted: 2018-06-25
• Last Update Posted: 2018-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ISIS-FGFR4RX	ISIS-FGFR4RX	ISIS-FGFR4RX administered subcutaneously
Placebo	Placebo	Placebo administered subcutaneously

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Translational Research Institute for Metabolism and Diabetes; 🇺🇸 Orlando, Florida, United States