Impact of Liraglutide 3.0 on Body Fat Distribution

NCT03038620 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STU 122015-044
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Visceral; Cardiovascular Diseases; Fat Disorder

Keywords

Obesity; Visceral; Cardiovascular Disease; Fat

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 40 weeks

Secondary Outcomes (35)

• Absolute Reduction in Visceral Adipose Tissue Volume

  Baseline, 40 weeks

• Relative Percent Reduction in Body Weight

  Baseline, 40 weeks

• Absolute Reduction in Body Weight

  Baseline, 40 weeks

• Relative Percent Reduction in Waist Circumference

  Baseline, 40 weeks

• Absolute Reduction in Waist Circumference

  Baseline, 40 weeks

Other Outcomes (1)

• On-treatment Time, Weeks

  weeks

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Liraglutide DRUG

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.

Also known as: Saxenda

Liraglutide 3.0 mg

Placebo DRUG

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.

Also known as: Saline injection

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (26)

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MeSH Terms

Conditions

Obesity, Abdominal; Cardiovascular Diseases; Lipid Metabolism Disorders; Obesity; Platelet Glycoprotein IV Deficiency

Interventions

Liraglutide; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Parag Joshi
• Organization: UT Southwestern Medical Center

parag.joshi@utsouthwestern.edu

2146458000

Study Officials

• Parag Joshi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: January 31, 2017
• Study Start: January 1, 2017
• Primary Completion: October 13, 2020
• Study Completion: October 13, 2020
• Last Updated: November 19, 2021
• Results First Posted: November 19, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)