Monoclonal GammopathiesPhase 4NCT02920190
Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat
A Phase 4 study testing Liraglutide in people with Monoclonal Gammopathies and Overweight, run by University of Miami.
Trial summary
The purpose of this research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Monoclonal Gammopathies, Overweight, Obesity
- What is being tested?
- Liraglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Dec 2021
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI ≥27 kg/m2
- At least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes [IFG, IGT], hypertension, dyslipidemia)
- Age > 18 and < 70 years old
Who cannot join
- Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®
- Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
- Insulin dependent or treated type 2 diabetes
- Current use of other injectable incretins
- History of diabetes ketoacidosis
- Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2
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- Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
- Clinical or laboratory evidences of chronic active liver diseases
- Acute or chronic infective diseases
- Known or suspected allergy to Liraglutide, excipients, or related products
- Pregnant, breast-feeding or the intention of becoming pregnant
- Females of childbearing potential who are not using adequate contraceptive methods
About this study
Official title: Reduction of Antigen-Lipid-Driven Monoclonal Gammopathies by Targeting Epicardial Fat and Its Lipids Content With Liraglutide: A Glucagon Like Peptide-1 Receptor Analogue (GLP-1RA)
The purpose of this research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood.
- Conditions
- Monoclonal Gammopathies, Overweight, Obesity
- Being tested
- Liraglutide
- Medical subject headings
- Paraproteinemias, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide Group | Experimental | Participants in this group will receive the Liraglutide intervention for 12 months Receives: Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Epicardial Fat Thickness
Epicardial fat thickness measured in mm via ultrasound
Measured: Baseline, 12 months
Secondary outcomes (2)
Change in serum immunoglobulins
Immunoglobin levels assessed in g/L will be evaluated using serum blood samples
Measured: Baseline, 12 months
Change in plasma ceramide levels
Plasma ceramide levels will be evaluated in umol/L
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study start1 Sep 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: Lack of funds to cover the costs of the study medications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoclonal GammopathiesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Hoffman, MD, University of Miami
- Investigators
- James Hoffman, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02920190
- Sponsor's protocol ID
- 20160568
- Status last verified
- Sep 2020
- First submitted
- 22 Aug 2016
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Antigen-Lipid-Driven Monoclonal Gammopathies by Targeting Epicardial Fat and Its Lipids Content With Liraglutide: A Glucagon Like Peptide-1 Receptor Analogue (GLP-1RA)
- ClinicalTrials.gov ID
- NCT02920190
- Acronym / sponsor ID
- 20160568
- Conditions
- Monoclonal Gammopathies, Overweight, Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds to cover the costs of the study medications
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Sep 2016 (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 research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liraglutide Group | Experimental | Drug: LiraglutideParticipants in this group will receive the Liraglutide intervention for 12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI ≥27 kg/m2
- At least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes [IFG, IGT], hypertension, dyslipidemia)
- Age > 18 and < 70 years old
Key exclusion criteria (12 listed)
- Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®
- Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
- Insulin dependent or treated type 2 diabetes
- Current use of other injectable incretins
- History of diabetes ketoacidosis
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 |
|---|---|---|
| LiraglutideAlso: Victoza1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months | Drug | Liraglutide Group |
Primary outcome
Change in Epicardial Fat Thickness
Time frame: Baseline, 12 months
Epicardial fat thickness measured in mm via ultrasound
2 secondary outcomes
Change in serum immunoglobulins
Time frame: Baseline, 12 months
Change in plasma ceramide levels
Time frame: Baseline, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: No
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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.
James Hoffman, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide in people with Monoclonal Gammopathies and Overweight, run by University of Miami.
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 3 inclusion and 12 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: withdrawn, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Epicardial Fat Thickness (time frame: Baseline, 12 months). 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 21 Sep 2020.