Primary outcomeMean· Baseline, 40 weeks
Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI
| Group | Value (percentage of reduction in VAT) |
|---|---|
| Liraglutide 3.0 mg | 12.49 |
| Placebo | 1.63 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataImpact of Liraglutide 3.0 on Body Fat Distribution
NCTNCT03038620 (opens ClinicalTrials.gov in a new tab)Other idSTU 122015-044
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 235 participants (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- Jan 2017
- Primary completion
- 13 Oct 2020
- Completion
- 13 Oct 2020
- First posted
- 31 Jan 2017 (estimated)
- Last update posted
- 19 Nov 2021
- Conditions
- Obesity, Visceral · Cardiovascular Diseases · Fat Disorder
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20172018201920202021
- Ph 4
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LiraglutideDrug
- PlaceboDrug
Arms2
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.
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment. Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Secondary outcomes(20)
Absolute Reduction in Visceral Adipose Tissue Volume
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Relative Percent Reduction in Body Weight
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Absolute Reduction in Body Weight
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Relative Percent Reduction in Waist Circumference
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Absolute Reduction in Waist Circumference
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Relative Percent Reduction in Total Body Adipose Tissue
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Absolute Reduction in Total Body Adipose Tissue
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.
Absolute Reduction in Abdominal Subcutaneous Adipose Tissue
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.
Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.
Absolute Reduction in Lower Body Subcutaneous Adipose Tissue
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.
Relative Percent Reduction in Liver Fat Percent
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Absolute Reduction in Liver Fat Percent
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk.
Relative Percent Reduction in Total Body Lean Volume
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.
Absolute Reduction in Total Body Lean Volume
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.
Relative Percent Reduction in Total Thigh Muscle Volume
Time frame · Baseline, 40 weeks
Registry description
The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.
Absolute Reduction in Total Thigh Muscle Volume
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint.
Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time frame · Baseline,40 weeks
Registry description
The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower risk for metabolic disease.
Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time frame · Baseline,40 weeks
Registry description
The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower risk for metabolic disease
Change From Baseline in VAT/SAT Ratio
Time frame · Baseline, 40 weeks
Registry description
The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, 40 weeks
Absolute Reduction in Visceral Adipose Tissue Volume
| Group | Value (Liters) | Spread |
|---|---|---|
| Liraglutide 3.0 mg | 0.53 | 0.43 |
| Placebo | 0.10 | 0.53 |
Secondary outcomeMean· Baseline, 40 weeks
Relative Percent Reduction in Body Weight
| Group | Value (percent change) | Spread |
|---|---|---|
| Liraglutide 3.0 mg | 6.59 | 4.80 |
| Placebo | 1.19 | 4.68 |
Secondary outcomeMean· Baseline, 40 weeks
Absolute Reduction in Body Weight
| Group | Value (Kilograms) | Spread |
|---|---|---|
| Liraglutide 3.0 mg | 6.75 | 5.35 |
| Placebo | 1.3 | 4.79 |
Secondary outcomeMean· Baseline, 40 weeks
Relative Percent Reduction in Waist Circumference
| Group | Value (percent change) | Spread |
|---|---|---|
| Liraglutide 3.0 mg | 6.90 | 6.43 |
| Placebo | 4.16 | 6.06 |
Secondary outcomeMean· Baseline, 40 weeks
Absolute Reduction in Waist Circumference
| Group | Value (cm) | Spread |
|---|---|---|
| Liraglutide 3.0 mg | 7.4 | 6.8 |
| Placebo | 4.6 | 6.7 |
Secondary outcomeMean· Baseline, 40 weeks
Relative Percent Reduction in Total Body Adipose Tissue
| Group | Value (percent change) | Spread |
|---|---|---|
| Liraglutide 3.0 mg | 9.59 | 7.15 |
| Placebo | 0.95 | 7.80 |
Secondary outcomeMean· Baseline, 40 weeks
Absolute Reduction in Total Body Adipose Tissue
| Group | Value (Liters) | Spread |
|---|---|---|
| Liraglutide 3.0 mg | 3.76 | 2.87 |
| Placebo | 0.42 | 2.92 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Liraglutide 3.0 mgDrug: 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. 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. | 0 / 92 | 0 / 92 | 53 / 92 |
| PlaceboDrug: 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. 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. | 0 / 93 | 0 / 93 | 34 / 93 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies4
Studies that cite this trial.
More studies
4 studies on this page
PubMed tag: none · 2021
Effects of liraglutide on visceral and ectopic fat in adults with overweight and obesity at high cardiovascular risk: a randomised, double-blind, placebo-controlled, clinical trial.
Neeland et al. 2021The lancet. Diabetes & endocrinologycited by 162
PMID 34358471DOI 10.1016/s2213-8587(21)00179-0PUB-34358471
Full text at the publisher
Indexing hint: Randomized controlled trial · 2013
Corrected
Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study.
Wadden et al. 2013International journal of obesity (2005)cited by 544
PMID 23812094DOI 10.1038/ijo.2013.120PUB-23812094
Full text at the publisher
Indexing hint: Randomized controlled trial · 2012
Corrected
Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide.
Astrup et al. 2012International journal of obesity (2005)cited by 497
PMID 21844879PMC3374073DOI 10.1038/ijo.2011.158PUB-21844879
Free to read · publisher termsCC BY-NC-ND
Indexing hint: Randomized controlled trial · 2009
Corrected
Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study.
Astrup et al. 2009Lancet (London, England)cited by 810
PMID 19853906DOI 10.1016/s0140-6736(09)61375-1PUB-19853906
Full text at the publisher
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 35 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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 Glucagon-like peptide-1 (GLP-1) receptor agonists (including liraglutide, exenatide or others as they become available), dipeptidyl peptidase 4 (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, chlorpromazine, 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 spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.
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