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

NCT02476019 | Completed Phase 2

• 1 other identifier: ISIS 463588-CS2
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity

Keywords

Obesity; Energy Expenditure

Outcome Measures

Primary Outcomes (1)

• Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry

  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)

  From baseline to the average of weeks 14 and 16

Secondary Outcomes (1)

• 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

Study Arms (2)

ISIS-FGFR4RX

EXPERIMENTAL

ISIS-FGFR4RX administered subcutaneously

Drug: ISIS-FGFR4RX

Placebo

PLACEBO COMPARATOR

Placebo administered subcutaneously

Drug: Placebo

Interventions

ISIS-FGFR4RX DRUG

ISIS-FGFR4RX administered subcutaneously

Also known as: ISIS 463588

ISIS-FGFR4RX

Placebo DRUG

Placebo administered subcutaneously

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ionis Pharmaceuticals, Inc.: lead

Study Sites (1)

Translational Research Institute for Metabolism and Diabetes

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 19, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 25, 2018

Record last verified: 2018-06

Locations

US (1)