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Impact of Liraglutide 3.0 on Body Fat Distribution

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ClinicalTrials.gov Identifier: NCT03038620
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Parag Joshi, University of Texas Southwestern Medical Center

Brief Summary:
This study is a clinical study to investigate the efficacy of liraglutide compared to placebo in reducing visceral adiposity measured by MRI in overweight or obese subjects at high risk for cardiovascular disease after 40 weeks on-treatment.

Condition or disease Intervention/treatment Phase
Obesity, Visceral Cardiovascular Diseases Fat Disorder Drug: Liraglutide Drug: Placebo Phase 4

Detailed Description:
Obesity has long been recognized as a risk factor for all-cause mortality and morbidity, including the development of cardiovascular and metabolic diseases such as coronary artery disease, hypertension, insulin resistance, diabetes, and dyslipidemia. Obesity has recently been formally defined as a chronic disease characterized by pathophysiological processes that result in increased adipose tissue mass and can result in increased morbidity and mortality. Although the health risks associated with obesity are clear, there is an emerging appreciation that obesity per se, as defined by simple anthropometric measures such as waist circumference or body mass index (BMI), is neither necessary nor sufficient to promote cardiometabolic disease and atherosclerotic cardiovascular disease (ASCVD) risk. As a result, BMI alone is an insufficient marker of risk and may not accurately identify individuals at elevated risk for ASCVD. There is a pressing need to more accurately phenotype obesity to identify individuals at elevated risk for ASCVD that may benefit from more intensive preventive and therapeutic strategies

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 356 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease
Actual Study Start Date : January 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Experimental: Liraglutide 3.0 mg

Drug: Liraglutide Active Drug

Other Names:

  • Saxenda

Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.

Drug: Liraglutide
Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Other Name: Saxenda

Placebo Comparator: Placebo

Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL

Other Names:

  • Placebo
  • Saline injection

Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.

Drug: Placebo
Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Other Name: Saline injection




Primary Outcome Measures :
  1. Liraglutide Treatment effect on relative percent change from baseline in visceral adipose tissue mass measured by MRI [ Time Frame: 40 weeks ]
    The liraglutide treatment effect on relative percent change from baseline in visceral adipose tissue mass measured by MRI.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 35 years
  • Able to provide informed consent
  • BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with metabolic syndrome
  • Metabolic syndrome is defined as at least three of the following:3

    1. waist circumference > 102 cm (40 in) in men and 88 cm (35 in) in women
    2. triglycerides > 150 mg/dL or on treatment for hypertriglyceridemia
    3. HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women
    4. blood pressure > 130/85 mmHg or on treatment for hypertension
    5. fasting glucose > 100 mg/dL

Exclusion Criteria:

  • Treatment with GLP-1 receptor agonists (including liraglutide, exenatide or others as they become available), DPP-4 inhibitors or insulin within the last 3 months.
  • Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial.
  • Self-reported or clinically documented history of significant fluctuations (>5% change) in weight within 3 months prior to screening for this trial.
  • History of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes medication.
  • History of chronic pancreatitis or idiopathic acute pancreatitis (current or prior history).
  • History of gallbladder disease (cholelithiasis or cholecystitis).
  • Chronic kidney disease stage III or greater (eGFR<60 mL/min).
  • Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome).
  • Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, clorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
  • Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening for this trial.
  • Current participation in an organized weight reduction program or within the last 1 month prior to screening for this trial.
  • Participation in a clinical trial within the last 3 months prior to screening for this trial.
  • Familial or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
  • Personal history of non-familial medullary thyroid carcinoma.
  • History of Major Depressive Disorder within the last 2 years.
  • History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder.
  • Any lifetime history of a suicide attempt.
  • A history of any suicidal behavior in the last month prior to randomization.
  • Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
  • Known or suspected hypersensitivity to trial product(s) or related product(s).
  • Known or suspected abuse of alcohol or narcotics.
  • Language barrier, mental incapacity, unwillingness or inability to understand.
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermacide, condom with spermacide (by male partner), intrauterine device, sponge, spermacide, Norplant®, Depo-Provera® or oral contraceptives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038620


Contacts
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Contact: Bienka Lewis, MPH 214-648-2091 Bienka.Milton@utsouthwestern.edu

Locations
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United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Bienka Lewis, MPH    214-648-2091    bienka.milton@utsouthwestern.edu   
Principal Investigator: Parag Joshi, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Novo Nordisk A/S
Investigators
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Principal Investigator: Parag Joshi, MD University of Texas Southwestern Medical Center

Publications:

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Responsible Party: Parag Joshi, M.D., University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03038620     History of Changes
Other Study ID Numbers: STU-122015-044
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Parag Joshi, University of Texas Southwestern Medical Center:
Obesity
Visceral
Cardiovascular Disease
Fat
Additional relevant MeSH terms:
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Obesity, Abdominal
Cardiovascular Diseases
Obesity
Overnutrition
Nutrition Disorders
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists