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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide 3.0 mg | Experimental | Drug: Liraglutide Active Drug Other Names:
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: 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:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 40 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| On-treatment Time, Weeks | The mean duration of treatment during study follow-up. | weeks |
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Parag Joshi, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19853906 | Background | 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. | |
| 21844879 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide 3.0 mg | Drug: Liraglutide Active Drug Other Names:
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. |
| FG001 | 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:
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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants analyzed if they completed an endpoint assessment and had interpretable imaging data.
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| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide 3.0 mg | Drug: Liraglutide Active Drug Other Names:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Those who completed study endpoint assessment (interpretable MRI at baseline and at study end). | Posted | Mean | 95% Confidence Interval | percentage of reduction in VAT | Baseline, 40 weeks |
|
For the entire duration of the study: 40 weeks.
Adverse events collected at each study visit. GI side effects captured and reported in summary form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide 3.0 mg | Drug: Liraglutide Active Drug Other Names:
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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| GI related | Gastrointestinal disorders | Systematic Assessment | Constipation, nausea/vomiting, upset stomach, diarrhea |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Parag Joshi | UT Southwestern Medical Center | 2146458000 | parag.joshi@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2018 | Oct 15, 2021 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 28, 2020 | Oct 15, 2021 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D056128 | Obesity, Abdominal |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D009765 | Obesity |
| C564245 | Platelet Glycoprotein IV Deficiency |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
|
| 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. |
|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | Baseline, 40 weeks |
| Absolute Change in Fasting Blood Glucose | The change in fasting blood glucose from baseline to study end point by treatment group. | 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. | 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. | 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. | 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. | 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. | Baseline, 40 weeks |
| Change From Baseline in Heart Rate | The change in heart rate/pulse from baseline to study endpoint visit by treatment group. | Baseline, 40 weeks |
| Change From Baseline in Blood Pressure | The change in systolic blood pressure from baseline to study endpoint visit by treatment group. | Baseline, 40 weeks |
| 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. |
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| 26768490 | Background | Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed. 2015 Dec;28(12):1747-53. doi: 10.1002/nbm.3432. Epub 2015 Nov 2. |
| 25808071 | Background | Schaudinn A, Linder N, Garnov N, Kerlikowsky F, Bluher M, Dietrich A, Schutz T, Karlas T, Kahn T, Busse H. Predictive accuracy of single- and multi-slice MRI for the estimation of total visceral adipose tissue in overweight to severely obese patients. NMR Biomed. 2015 May;28(5):583-90. doi: 10.1002/nbm.3286. Epub 2015 Mar 25. |
| 25343445 | Background | Dong Z, Luo Y, Zhang Z, Cai H, Li Y, Chan T, Wu L, Li ZP, Feng ST. MR quantification of total liver fat in patients with impaired glucose tolerance and healthy subjects. PLoS One. 2014 Oct 24;9(10):e111283. doi: 10.1371/journal.pone.0111283. eCollection 2014. |
| 24871333 | Background | Thomas MS, Newman D, Leinhard OD, Kasmai B, Greenwood R, Malcolm PN, Karlsson A, Rosander J, Borga M, Toms AP. Test-retest reliability of automated whole body and compartmental muscle volume measurements on a wide bore 3T MR system. Eur Radiol. 2014 Sep;24(9):2279-91. doi: 10.1007/s00330-014-3226-6. Epub 2014 May 29. |
| 15810802 | Background | Human energy requirements: report of a joint FAO/ WHO/UNU Expert Consultation. Food Nutr Bull. 2005 Mar;26(1):166. No abstract available. |
| 34358471 | Derived | Neeland IJ, Marso SP, Ayers CR, Lewis B, Oslica R, Francis W, Rodder S, Pandey A, Joshi PH. 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. Lancet Diabetes Endocrinol. 2021 Sep;9(9):595-605. doi: 10.1016/S2213-8587(21)00179-0. Epub 2021 Aug 3. |
| Uninterpretable Outcome (Imaging) |
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| BG001 | 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:
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total Adipose tissue | Mean | Standard Deviation | Liters |
|
| Visceral Adipose Tissue | Mean | Standard Deviation | Liters |
|
| Abdominal Adipose Tissue | Mean | Standard Deviation | Liters |
|
| Lower Body Adipose Tissue | MRI based quantification of adipose tissue from the lower body. | Mean | Standard Deviation | Liters |
|
| Liver Fat | Mean | Standard Deviation | percentage of fat |
|
| Total Body Lean Tissue | Mean | Standard Deviation | Liters |
|
| Fasting Blood Glucose | Mean | Standard Deviation | mg/dL |
|
| Fasting Insulin | Mean | Standard Deviation | mIU/L |
|
| Triglycerides (mg/dL) | Mean | Standard Deviation | mg/dL |
|
| C-reactive Protein (mg/L) | Mean | Standard Deviation | mg/L |
|
| N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (pg/mL) | Mean | Standard Deviation | pg/mL |
|
| Number of Participants with Hypertension | Count of Participants | Participants |
|
| Number of Participants with Hyperlipidemia | Count of Participants | Participants |
|
| Number of Participants with Prediabetes | Count of Participants | Participants |
|
| Systolic blood pressure (mmHg) | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure (mmHg) | Mean | Standard Deviation | mmHg |
|
| Weight (kg) | Mean | Standard Deviation | Kg |
|
| Height (m) | Mean | Standard Deviation | m |
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| BMI (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference (cm) | Mean | Standard Deviation | cm |
|
| Baseline kcal/day | Mean | Standard Deviation | kcal/day |
|
| OG001 | 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:
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. |
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | Liters | Baseline, 40 weeks |
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | Kilograms | Baseline, 40 weeks |
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | cm | Baseline, 40 weeks |
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
|
|
| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | Liters | Baseline, 40 weeks |
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | Liters | Baseline, 40 weeks |
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|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
|
|
| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | Liters | Baseline, 40 weeks |
|
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images are reported here. | Posted | Mean | Standard Deviation | percentage of liver fat | Baseline, 40 weeks |
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images are reported here. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images are reported here. | Posted | Mean | Standard Deviation | Liters | Baseline, 40 weeks |
|
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images are reported here. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images are reported here. | Posted | Mean | Standard Deviation | Liters | Baseline, 40 weeks |
|
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| Secondary | 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. | Those who completed baseline and endpoint MRI with interpretable images are reported here. | Posted | Mean | Standard Deviation | percent change | Baseline,40 weeks |
|
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| Secondary | 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 | Those who completed baseline and endpoint MRI with interpretable images are reported here. | Posted | Mean | Standard Deviation | percentage of fat infiltration | Baseline,40 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ratio | Baseline, 40 weeks |
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| Secondary | 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. | Posted | Mean | Standard Deviation | ratio | Baseline, 40 weeks |
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| Secondary | 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). | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
|
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | percent change | Baseline, 40 weeks |
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| Secondary | Absolute Change in Fasting Blood Glucose | The change in fasting blood glucose from baseline to study end point by treatment group. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | mg/dL | Baseline,40 weeks |
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | mIU/L | Baseline, 40 weeks |
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | Molar units | Baseline, 40 weeks |
|
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | mg/L | Baseline, 40 weeks |
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | ratio | Baseline, 40 weeks |
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| Secondary | 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. | Complete case analysis was done. Those who completed baseline and endpoint study visits and had results, were only analyzed and reported here. | Posted | Mean | Standard Deviation | pg/mL | Baseline, 40 weeks |
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| Secondary | Change From Baseline in Heart Rate | The change in heart rate/pulse from baseline to study endpoint visit by treatment group. | Posted | Mean | Standard Deviation | beats per minute | Baseline, 40 weeks |
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| Secondary | Change From Baseline in Blood Pressure | The change in systolic blood pressure from baseline to study endpoint visit by treatment group. | Posted | Mean | Standard Deviation | mmHg | Baseline, 40 weeks |
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| Other Pre-specified | On-treatment Time, Weeks | The mean duration of treatment during study follow-up. | Posted | Mean | Standard Deviation | weeks | weeks |
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|
| 0 |
| 92 |
| 0 |
| 92 |
| 53 |
| 92 |
| EG001 | 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:
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 |
|
| Respiratory Tract infection | Infections and infestations | Systematic Assessment | Upper Respiratory Infection (URI) or pharyngitis |
|
| Injection site reaction | Product Issues | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| insomnia | Nervous system disorders | Non-systematic Assessment |
|
| dizziness | Nervous system disorders | Non-systematic Assessment |
|
| fever | Immune system disorders | Non-systematic Assessment |
|
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008659 | Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |