Obesity, VisceralPhase 4NCT03038620

Impact of Liraglutide 3.0 on Body Fat Distribution

A Phase 4 study testing Liraglutide in people with Obesity, Visceral and Cardiovascular Diseases, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 35 years and olderHealthy volunteers can take part
Conditions the study is for: Obesity, Visceral, Cardiovascular Diseases, Fat Disorder
What is being tested?: Liraglutide
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 235 participants
Where: 1 siteUnited States
Study dates: Jan 2017to 13 Oct 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 35 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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
waist circumference > 102 cm (40 in) in men and 88 cm (35 in) in women
triglycerides > 150 mg/dL or on treatment for hypertriglyceridemia

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HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women
blood pressure > 130/85 mmHg or on treatment for hypertension
fasting glucose > 100 mg/dL

Who cannot join

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).

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Southwestern Medical Center
Dallas, Texas, 75390

Other trials in United States

About this study

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

Read the 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

Conditions: Obesity, Visceral, Cardiovascular Diseases, Fat Disorder
Being tested: Liraglutide, Placebo
Keywords: Obesity, Visceral, Cardiovascular Disease, Fat
Medical subject headings: Obesity, Abdominal, Cardiovascular Diseases, Lipid Metabolism Disorders, Obesity, Platelet Glycoprotein IV Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LiraglutideDrug
Also called Saxenda
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.
PlaceboDrug
Also called Saline injection
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.

Study groups in NCT03038620
Study group	Role	What they receive
Liraglutide 3.0 mg	Experimental	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. Receives: Drug: Liraglutide
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI
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.
Measured: Baseline, 40 weeks

Secondary outcomes (35)

Absolute Reduction in Visceral Adipose Tissue Volume
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Body Weight
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.
Measured: Baseline, 40 weeks
Absolute Reduction in Body Weight
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Waist Circumference
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.
Measured: Baseline, 40 weeks
Absolute Reduction in Waist Circumference
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Total Body Adipose Tissue
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.
Measured: Baseline, 40 weeks
Absolute Reduction in Total Body Adipose Tissue
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue
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.
Measured: Baseline, 40 weeks
Absolute Reduction in Abdominal Subcutaneous Adipose Tissue
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue
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.
Measured: Baseline, 40 weeks
Absolute Reduction in Lower Body Subcutaneous Adipose Tissue
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Liver Fat Percent
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.
Measured: Baseline, 40 weeks
Absolute Reduction in Liver Fat Percent
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Total Body Lean Volume
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.
Measured: Baseline, 40 weeks
Absolute Reduction in Total Body Lean Volume
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Total Thigh Muscle Volume
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.
Measured: Baseline, 40 weeks
Absolute Reduction in Total Thigh Muscle Volume
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.
Measured: Baseline, 40 weeks
Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
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.
Measured: Baseline,40 weeks
Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
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
Measured: Baseline,40 weeks
Change From Baseline in VAT/SAT Ratio
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.
Measured: Baseline, 40 weeks
Change From Baseline in Total Fat/Fat-free Mass Ratio
The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo.
This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better.
Measured: Baseline, 40 weeks
Relative Percent Change in Fasting Blood Glucose
The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL).
Measured: Baseline, 40 weeks
Relative Percent Change in Insulin
The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group.
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
This is a blood based biomarker in which lower fasting levels are desirable.
Measured: Baseline, 40 weeks
Relative Percent Change in HOMA-IR
The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group.
Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
The relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1.
Measured: Baseline, 40 weeks
Relative Percent Change in C-reactive Protein
The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.
Measured: Baseline, 40 weeks
Relative Percent Change in Triglyceride/HDL-C Ratio
The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.
Measured: Baseline, 40 weeks
Relative Percent Change in Nt-proBNP
The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group.
Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure.
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.
Measured: Baseline, 40 weeks
Absolute Change in Fasting Blood Glucose
The change in fasting blood glucose from baseline to study end point by treatment group.
Measured: Baseline,40 weeks
Absolute Change in Insulin
The absolute change in insulin from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
Measured: Baseline, 40 weeks
Absolute Change in HOMA-IR
The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. Collection was impacted by COVID-19 and changes to study visits.
Measured: Baseline, 40 weeks
Absolute Change in CRP
The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events.
Measured: Baseline, 40 weeks
Absolute Change in Triglyceride/HDL-C Ratio
The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk.
Measured: Baseline, 40 weeks
Absolute Change in Nt-proBNP
The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits.
NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events.
Measured: Baseline, 40 weeks
Change From Baseline in Heart Rate
The change in heart rate/pulse from baseline to study endpoint visit by treatment group.
Measured: Baseline, 40 weeks
Change From Baseline in Blood Pressure
The change in systolic blood pressure from baseline to study endpoint visit by treatment group.
Measured: Baseline, 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201713 Oct 2020

First posted31 Jan 2017 (estimated)
Study startJan 2017
Primary completion13 Oct 2020
Study completion13 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Obesity, VisceralStudies of the same condition, open and under way.
More trials run by University of Texas Southwestern Medical CenterThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 235 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03038620
Sponsor's protocol ID: STU 122015-044
Status last verified: Oct 2021
First submitted: 30 Jan 2017
Last updated: 19 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.
PubMed 19853906
Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16.
PubMed 21844879
Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.
PubMed 18340209
Berrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ, Moore SC, Tobias GS, Anton-Culver H, Freeman LB, Beeson WL, Clipp SL, English DR, Folsom AR, Freedman DM, Giles G, Hakansson N, Henderson KD, Hoffman-Bolton J, Hoppin JA, Koenig KL, Lee IM, Linet MS, Park Y, Pocobelli G, Schatzkin A, Sesso HD, Weiderpass E, Willcox BJ, Wolk A, Zeleniuch-Jacquotte A, Willett WC, Thun MJ. Body-mass index and mortality among 1.46 million white adults. N Engl J Med. 2010 Dec 2;363(23):2211-9. doi: 10.1056/NEJMoa1000367.
PubMed 21121834
Despres JP. Body fat distribution and risk of cardiovascular disease: an update. Circulation. 2012 Sep 4;126(10):1301-13. doi: 10.1161/CIRCULATIONAHA.111.067264. No abstract available.
PubMed 22949540
Garvey WT, Garber AJ, Mechanick JI, Bray GA, Dagogo-Jack S, Einhorn D, Grunberger G, Handelsman Y, Hennekens CH, Hurley DL, McGill J, Palumbo P, Umpierrez G; The Aace Obesity Scientific Committee. American association of clinical endocrinologists and american college of endocrinology position statement on the 2014 advanced framework for a new diagnosis of obesity as a chronic disease. Endocr Pract. 2014 Sep;20(9):977-89. doi: 10.4158/EP14280.PS. No abstract available.
PubMed 25253227
Morkedal B, Vatten LJ, Romundstad PR, Laugsand LE, Janszky I. Risk of myocardial infarction and heart failure among metabolically healthy but obese individuals: HUNT (Nord-Trondelag Health Study), Norway. J Am Coll Cardiol. 2014 Mar 25;63(11):1071-8. doi: 10.1016/j.jacc.2013.11.035. Epub 2013 Dec 15.
PubMed 24345592
Despres JP, Lemieux I, Bergeron J, Pibarot P, Mathieu P, Larose E, Rodes-Cabau J, Bertrand OF, Poirier P. Abdominal obesity and the metabolic syndrome: contribution to global cardiometabolic risk. Arterioscler Thromb Vasc Biol. 2008 Jun;28(6):1039-49. doi: 10.1161/ATVBAHA.107.159228. Epub 2008 Mar 20.
PubMed 18356555
McLaughlin T, Lamendola C, Liu A, Abbasi F. Preferential fat deposition in subcutaneous versus visceral depots is associated with insulin sensitivity. J Clin Endocrinol Metab. 2011 Nov;96(11):E1756-60. doi: 10.1210/jc.2011-0615. Epub 2011 Aug 24.
PubMed 21865361
McLaughlin T, Sherman A, Tsao P, Gonzalez O, Yee G, Lamendola C, Reaven GM, Cushman SW. Enhanced proportion of small adipose cells in insulin-resistant vs insulin-sensitive obese individuals implicates impaired adipogenesis. Diabetologia. 2007 Aug;50(8):1707-15. doi: 10.1007/s00125-007-0708-y. Epub 2007 Jun 5.
PubMed 17549449
See R, Abdullah SM, McGuire DK, Khera A, Patel MJ, Lindsey JB, Grundy SM, de Lemos JA. The association of differing measures of overweight and obesity with prevalent atherosclerosis: the Dallas Heart Study. J Am Coll Cardiol. 2007 Aug 21;50(8):752-9. doi: 10.1016/j.jacc.2007.04.066. Epub 2007 Aug 6.
PubMed 17707180
Cerhan JR, Moore SC, Jacobs EJ, Kitahara CM, Rosenberg PS, Adami HO, Ebbert JO, English DR, Gapstur SM, Giles GG, Horn-Ross PL, Park Y, Patel AV, Robien K, Weiderpass E, Willett WC, Wolk A, Zeleniuch-Jacquotte A, Hartge P, Bernstein L, Berrington de Gonzalez A. A pooled analysis of waist circumference and mortality in 650,000 adults. Mayo Clin Proc. 2014 Mar;89(3):335-45. doi: 10.1016/j.mayocp.2013.11.011.
PubMed 24582192
Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.
PubMed 16182882
Hsu WC, Araneta MR, Kanaya AM, Chiang JL, Fujimoto W. BMI cut points to identify at-risk Asian Americans for type 2 diabetes screening. Diabetes Care. 2015 Jan;38(1):150-8. doi: 10.2337/dc14-2391. No abstract available.
PubMed 25538311
Neeland IJ, Ayers CR, Rohatgi AK, Turer AT, Berry JD, Das SR, Vega GL, Khera A, McGuire DK, Grundy SM, de Lemos JA. Associations of visceral and abdominal subcutaneous adipose tissue with markers of cardiac and metabolic risk in obese adults. Obesity (Silver Spring). 2013 Sep;21(9):E439-47. doi: 10.1002/oby.20135. Epub 2013 May 19.
PubMed 23687099

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03038620
Acronym / sponsor ID: STU 122015-044
Conditions: Obesity, Visceral, Cardiovascular Diseases, Fat Disorder
Keywords: Obesity, Visceral, Cardiovascular Disease, Fat
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 235 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: Novo Nordisk A/S
Study start: Jan 2017 (actual)
Primary completion: 13 Oct 2020 (actual)
Study completion: 13 Oct 2020 (actual)
First posted: 31 Jan 2017 (estimated)
Results: Posted 19 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Liraglutide 3.0 mg	Experimental	Drug: LiraglutideDrug: 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	Placebo comparator	Drug: 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.

Who may qualify

Ages: 35 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (23 listed)

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).

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: SaxendaLiraglutide 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.	Drug	Liraglutide 3.0 mg
PlaceboAlso: Saline injectionPlacebo 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.	Drug	Placebo

Primary outcome

Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI
Time frame: Baseline, 40 weeks
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.

35 secondary outcomes

Absolute Reduction in Visceral Adipose Tissue Volume
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Body Weight
Time frame: Baseline, 40 weeks
Absolute Reduction in Body Weight
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Waist Circumference
Time frame: Baseline, 40 weeks
Absolute Reduction in Waist Circumference
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Total Body Adipose Tissue
Time frame: Baseline, 40 weeks
Absolute Reduction in Total Body Adipose Tissue
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue
Time frame: Baseline, 40 weeks
Absolute Reduction in Abdominal Subcutaneous Adipose Tissue
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue
Time frame: Baseline, 40 weeks
Absolute Reduction in Lower Body Subcutaneous Adipose Tissue
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Liver Fat Percent
Time frame: Baseline, 40 weeks
Absolute Reduction in Liver Fat Percent
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Total Body Lean Volume
Time frame: Baseline, 40 weeks
Absolute Reduction in Total Body Lean Volume
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Total Thigh Muscle Volume
Time frame: Baseline, 40 weeks
Absolute Reduction in Total Thigh Muscle Volume
Time frame: Baseline, 40 weeks
Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time frame: Baseline,40 weeks
Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time frame: Baseline,40 weeks
Change From Baseline in VAT/SAT Ratio
Time frame: Baseline, 40 weeks
Change From Baseline in Total Fat/Fat-free Mass Ratio
Time frame: Baseline, 40 weeks
Relative Percent Change in Fasting Blood Glucose
Time frame: Baseline, 40 weeks
Relative Percent Change in Insulin
Time frame: Baseline, 40 weeks
Relative Percent Change in HOMA-IR
Time frame: Baseline, 40 weeks
Relative Percent Change in C-reactive Protein
Time frame: Baseline, 40 weeks
Relative Percent Change in Triglyceride/HDL-C Ratio
Time frame: Baseline, 40 weeks
Relative Percent Change in Nt-proBNP
Time frame: Baseline, 40 weeks
Absolute Change in Fasting Blood Glucose
Time frame: Baseline,40 weeks
Absolute Change in Insulin
Time frame: Baseline, 40 weeks
Absolute Change in HOMA-IR
Time frame: Baseline, 40 weeks
Absolute Change in CRP
Time frame: Baseline, 40 weeks
Absolute Change in Triglyceride/HDL-C Ratio
Time frame: Baseline, 40 weeks
Absolute Change in Nt-proBNP
Time frame: Baseline, 40 weeks
Change From Baseline in Heart Rate
Time frame: Baseline, 40 weeks
Change From Baseline in Blood Pressure
Time frame: Baseline, 40 weeks

Results and safety

Results posted to the registry on 19 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liraglutide 3.0 mg	92	73
Placebo	93	55

Primary outcome: Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI

Time frame: Baseline, 40 weeks. Mean (95% Confidence Interval). Unit: percentage of reduction in VAT

Measure	Liraglutide 3.0 mg n = 73	Placebo n = 55
Value	12.49 (10.4 to 14.6)	1.63 (-1.62 to 4.88)

Population analysed: Those who completed study endpoint assessment (interpretable MRI at baseline and at study end).

35 secondary outcomes are reported in the full results.

Adverse events

Time frame: For the entire duration of the study: 40 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liraglutide 3.0 mg	0 of 92 (0%)	53 of 92 (57.6%)	0 of 92
Placebo	0 of 93 (0%)	34 of 93 (36.6%)	0 of 93

Limitations and caveats (from the sponsor): Results reported according to updated statistical analysis plan published 7/28/2020 on CT.gov website. The updated 7/28/2020 analysis plan accounted for changes in data collection (blood biomarkers) during COVID-19 pandemic and was submitted and published prior to study completion and prior to study un-blinding with updated terminology for study endpoints compared to original protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19853906Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23.
Background: PubMed 21844879Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16.
Background: PubMed 18340209Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.
Background: PubMed 21121834Berrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ, Moore SC, Tobias GS, Anton-Culver H, Freeman LB, Beeson WL, Clipp SL, English DR, Folsom AR, Freedman DM, Giles G, Hakansson N, Henderson KD, Hoffman-Bolton J, Hoppin JA, Koenig KL, Lee IM, Linet MS, Park Y, Pocobelli G, Schatzkin A, Sesso HD, Weiderpass E, Willcox BJ, Wolk A, Zeleniuch-Jacquotte A, Willett WC, Thun MJ. Body-mass index and mortality among 1.46 million white adults. N Engl J Med. 2010 Dec 2;363(23):2211-9. doi: 10.1056/NEJMoa1000367.
Background: PubMed 22949540Despres JP. Body fat distribution and risk of cardiovascular disease: an update. Circulation. 2012 Sep 4;126(10):1301-13. doi: 10.1161/CIRCULATIONAHA.111.067264. No abstract available.
Background: PubMed 25253227Garvey WT, Garber AJ, Mechanick JI, Bray GA, Dagogo-Jack S, Einhorn D, Grunberger G, Handelsman Y, Hennekens CH, Hurley DL, McGill J, Palumbo P, Umpierrez G; The Aace Obesity Scientific Committee. American association of clinical endocrinologists and american college of endocrinology position statement on the 2014 advanced framework for a new diagnosis of obesity as a chronic disease. Endocr Pract. 2014 Sep;20(9):977-89. doi: 10.4158/EP14280.PS. No abstract available.
Background: PubMed 24345592Morkedal B, Vatten LJ, Romundstad PR, Laugsand LE, Janszky I. Risk of myocardial infarction and heart failure among metabolically healthy but obese individuals: HUNT (Nord-Trondelag Health Study), Norway. J Am Coll Cardiol. 2014 Mar 25;63(11):1071-8. doi: 10.1016/j.jacc.2013.11.035. Epub 2013 Dec 15.
Background: PubMed 18356555Despres JP, Lemieux I, Bergeron J, Pibarot P, Mathieu P, Larose E, Rodes-Cabau J, Bertrand OF, Poirier P. Abdominal obesity and the metabolic syndrome: contribution to global cardiometabolic risk. Arterioscler Thromb Vasc Biol. 2008 Jun;28(6):1039-49. doi: 10.1161/ATVBAHA.107.159228. Epub 2008 Mar 20.
Background: PubMed 21865361McLaughlin T, Lamendola C, Liu A, Abbasi F. Preferential fat deposition in subcutaneous versus visceral depots is associated with insulin sensitivity. J Clin Endocrinol Metab. 2011 Nov;96(11):E1756-60. doi: 10.1210/jc.2011-0615. Epub 2011 Aug 24.
Background: PubMed 17549449McLaughlin T, Sherman A, Tsao P, Gonzalez O, Yee G, Lamendola C, Reaven GM, Cushman SW. Enhanced proportion of small adipose cells in insulin-resistant vs insulin-sensitive obese individuals implicates impaired adipogenesis. Diabetologia. 2007 Aug;50(8):1707-15. doi: 10.1007/s00125-007-0708-y. Epub 2007 Jun 5.
Background: PubMed 17707180See R, Abdullah SM, McGuire DK, Khera A, Patel MJ, Lindsey JB, Grundy SM, de Lemos JA. The association of differing measures of overweight and obesity with prevalent atherosclerosis: the Dallas Heart Study. J Am Coll Cardiol. 2007 Aug 21;50(8):752-9. doi: 10.1016/j.jacc.2007.04.066. Epub 2007 Aug 6.
Background: PubMed 24582192Cerhan JR, Moore SC, Jacobs EJ, Kitahara CM, Rosenberg PS, Adami HO, Ebbert JO, English DR, Gapstur SM, Giles GG, Horn-Ross PL, Park Y, Patel AV, Robien K, Weiderpass E, Willett WC, Wolk A, Zeleniuch-Jacquotte A, Hartge P, Bernstein L, Berrington de Gonzalez A. A pooled analysis of waist circumference and mortality in 650,000 adults. Mayo Clin Proc. 2014 Mar;89(3):335-45. doi: 10.1016/j.mayocp.2013.11.011.
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.

Parag Joshi, MD principal investigator

University of Texas Southwestern Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide in people with Obesity, Visceral and Cardiovascular Diseases, run by University of Texas Southwestern Medical Center 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 9 inclusion and 23 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 19 Nov 2021. 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 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?

Yes. Results are posted in the registry (first posted 19 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI (time frame: Baseline, 40 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03038620, which also lists 26 linked publications.

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 19 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.