ObesityPhase 2FGFR4-CS2NCT02476019
A Safety, Tolerability, PK, and PD Study of Once Weekly ISIS-FGFR4RX SC in Obese Patients
A Phase 2 study testing ISIS-FGFR4RX in people with Obesity, run by Ionis Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- ISIS-FGFR4RX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Translational Research Institute for Metabolism and Diabetes
Orlando, Florida, 32804
About this study
Official title: A Double Blind, Randomized, Placebo-controlled, Single Center, Phase 2a Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 463588 (ISIS-FGFR4RX, an Antisense Inhibitor of Fibroblast Growth Factor Receptor 4) Administered Subcutaneously Once Weekly for 13 Weeks in Obese Patients
The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX.
- Conditions
- Obesity
- Being tested
- ISIS-FGFR4RX, Placebo
- Keywords
- Obesity, Energy Expenditure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS-FGFR4RXDrug
Also called ISIS 463588
ISIS-FGFR4RX administered subcutaneously
PlaceboDrug
Placebo administered subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| ISIS-FGFR4RX | Experimental | ISIS-FGFR4RX administered subcutaneously Receives: Drug: ISIS-FGFR4RX |
| Placebo | Placebo comparator | Placebo administered subcutaneously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Safety results in patients dosed with ISIS 463588 will be compared with those from patients dosed with placebo
Measured: 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476019
- Sponsor's protocol ID
- ISIS 463588-CS2
- Acronym
- FGFR4-CS2
- Status last verified
- Jun 2018
- First submitted
- 15 Jun 2015
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo-controlled, Single Center, Phase 2a Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 463588 (ISIS-FGFR4RX, an Antisense Inhibitor of Fibroblast Growth Factor Receptor 4) Administered Subcutaneously Once Weekly for 13 Weeks in Obese Patients
- ClinicalTrials.gov ID
- NCT02476019
- Acronym / sponsor ID
- FGFR4-CS2 / ISIS 463588-CS2
- Conditions
- Obesity
- Keywords
- Obesity, Energy Expenditure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-FGFR4RX.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISIS-FGFR4RX | Experimental | Drug: ISIS-FGFR4RXISIS-FGFR4RX administered subcutaneously |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered subcutaneously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISIS-FGFR4RXAlso: ISIS 463588ISIS-FGFR4RX administered subcutaneously | Drug | ISIS-FGFR4RX |
| PlaceboPlacebo administered subcutaneously | Drug | Placebo |
Primary outcome
Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry
Time frame: 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)
1 secondary outcome
Safety and Tolerability will be assessed by determining the incidence, and severity of adverse effects and changes in laboratory evaluations within each treatment group.
Time frame: 33 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ISIS-FGFR4RX in people with Obesity, run by Ionis Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy Expenditure using both room calorimetry and hood (metabolic cart) calorimetry (time frame: From baseline to the average of weeks 14 and 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.