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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR SAXENDA

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Clinical Trials for Saxenda

Trial ID Title Status Sponsor Phase Summary
NCT02488057 Improving Beta Cell Function in Mexican American Women With Prediabetes Recruiting Ohio State University Phase 4 This study will examine the benefits of weight loss alone or in combination with a GLP1 receptor agonist, liraglutide, on beta cell function in young adult Mexican American (MA) women with prediabetes. The Investigators have chosen to focus on MA women because MA women are at very high risk for progression to diabetes and have not traditionally been involved in weight management studies since they are thought to be difficult to recruit and retain in such programs. However, investigators have had particular success in working with young MA women using specifically developed ethnic and gender conscious programs. Because weight loss does not prevent all progression to diabetes, some participants will receive the diabetes medication, liraglutide, which has been shown to stabilize beta cell function. The study will also interrogate for polymorphisms of known T2DM genes to correlate with beta cell response to weight loss and liraglutide treatment. Additionally, this investigation targets serious health disparities in metabolic disease in a highly vulnerable, rapidly growing population, testing novel gender and culturally focused intervention strategies and identifying genetic biomarkers of response to a pharmacologic intervention that targets the pancreatic ßcell. These results will help to a) understand mechanisms of disease, b) personalize treatment through identification of a high risk group that may be amenable to specific therapy, and c) ultimately, sets the stage for an intervention trial to prevent diabetes, a major chronic and costly disease, in Mexican Americans.
NCT02773355 Timely Detection of Pancreatitis Cases as Well as Cases of Suspicion of Serious and Non-serious Adverse Reactions Possibly or Probably Related to Saxenda® in Mexican Patients Enrolling by invitation Novo Nordisk A/S N/A This trial is conducted in North America. The aim is to investigate timely detection of pancreatitis cases as well as cases of suspicion of serious and non-serious adverse reactions possibly or probably related to Saxenda® in Mexican patients.
NCT02911818 Lifestyle Modification and Liraglutide Recruiting Novo Nordisk A/S Phase 4 This is a 52 week, single center, open-labeled, randomized controlled trial. A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as contraindications to weight loss, will be randomly assigned to one of three treatment groups: 1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e., CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component Intervention). Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration of counseling visits recommended by CMS. Counseling sessions will be delivered by a physician, nurse practitioner or registered dietitian (RD) working in consultation with the former providers. Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24, 36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide groups to monitor their response to the medication. These visits are included for subjects in CMS-Alone to match the intensity of medical care provided the two other groups. The primary outcome is % reduction in initial body weight, as measured from randomization to week 52. Secondary outcomes include the proportion of participants who at week 52 lose >5%, >10%, and >15% of initial weight, as well as % reduction in weight at week 24 and the proportion of participants who meet the three categorical weight losses at this time. The secondary efficacy measures include changes (from randomization to week 52) in cardiovascular disease (CVD) risk factors, glycemic control, mood, quality of life, eating behavior, appetite, sleep, and satisfaction with weight loss. Safety endpoints will include physical examination, adverse events (AEs), standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Statistical Analysis. Using a sample size equation for longitudinal clustered samples, a randomization sample of 50 subjects in CMS-Alone, 50 in CMS-Liraglutide, and 50 in the Multi-Component Intervention provides >80% power to detect the two primary contrasts to be statistically significant. This estimate allows for 20% attrition during the 52-week trial, resulting in approximately 40 treatment completers per group. The ITT longitudinal statistical design will further improve power by allowing the inclusion of available data for non-completers and the adjustment of possible variance reducing baseline covariates.
NCT02911818 Lifestyle Modification and Liraglutide Recruiting University of Pennsylvania Phase 4 This is a 52 week, single center, open-labeled, randomized controlled trial. A total of 150 subjects with obesity, who are free of types 1 and 2 diabetes, as well as contraindications to weight loss, will be randomly assigned to one of three treatment groups: 1) lifestyle counseling, as currently recommended by the Centers for Medicare and Medicaid Services (CMS) (i.e., CMS-Alone); 2) CMS lifestyle counseling plus liraglutide (i.e., CMS-Liraglutide); or 3) CMS-Liraglutide plus a portion-controlled diet (i.e., Multi-Component Intervention). Subjects in all three groups will have 14 brief (15 minute) lifestyle counseling visits the first 24 weeks, followed by monthly visits in weeks 25-52. This is the schedule and duration of counseling visits recommended by CMS. Counseling sessions will be delivered by a physician, nurse practitioner or registered dietitian (RD) working in consultation with the former providers. Subjects in all three groups also will have brief physician visits at weeks 1, 4, 8, 16, 24, 36, and 52 (total of 7 visits). These visits are needed for subjects in both liraglutide groups to monitor their response to the medication. These visits are included for subjects in CMS-Alone to match the intensity of medical care provided the two other groups. The primary outcome is % reduction in initial body weight, as measured from randomization to week 52. Secondary outcomes include the proportion of participants who at week 52 lose >5%, >10%, and >15% of initial weight, as well as % reduction in weight at week 24 and the proportion of participants who meet the three categorical weight losses at this time. The secondary efficacy measures include changes (from randomization to week 52) in cardiovascular disease (CVD) risk factors, glycemic control, mood, quality of life, eating behavior, appetite, sleep, and satisfaction with weight loss. Safety endpoints will include physical examination, adverse events (AEs), standard laboratory tests, and mental health assessed by the Columbia Suicidality Severity Rating Scale (C-SSRS) and Patient Health Questionnaire (PHQ-9). Statistical Analysis. Using a sample size equation for longitudinal clustered samples, a randomization sample of 50 subjects in CMS-Alone, 50 in CMS-Liraglutide, and 50 in the Multi-Component Intervention provides >80% power to detect the two primary contrasts to be statistically significant. This estimate allows for 20% attrition during the 52-week trial, resulting in approximately 40 treatment completers per group. The ITT longitudinal statistical design will further improve power by allowing the inclusion of available data for non-completers and the adjustment of possible variance reducing baseline covariates.
NCT02930265 Clinical Study of Liraglutide in Improving Cardiac Function for Patients With Ischemic Cardiomyopathy Enrolling by invitation Chinese PLA General Hospital N/A It has been known that liraglutide reduces infarct size, improved left ventricular function, reduce myocardial stunning, and play a protective role in myocardial ischemia-reperfusion injury for patients with acute myocardial infarction. But it is not sure whether liraglutide can benefit patients with ischemic cardiomyopathy. This study aim to explore the effect of Liraglutide in improving cardiac function for patients with ischemic cardiomyopathy.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Saxenda

Condition Name

Condition Name for Saxenda
Intervention Trials
Obesity 13
Parkinson Disease 1
Weight Loss 1
Cardiovascular Diseases 1
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Condition MeSH

Condition MeSH for Saxenda
Intervention Trials
Weight Loss 3
Obesity 3
Prediabetic State 2
Glucose Intolerance 2
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Clinical Trial Locations for Saxenda

Trials by Country

Trials by Country for Saxenda
Location Trials
United States 26
Denmark 2
United Kingdom 2
Canada 2
China 1
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Trials by US State

Trials by US State for Saxenda
Location Trials
Texas 3
Minnesota 2
New York 2
Massachusetts 2
Pennsylvania 2
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Clinical Trial Progress for Saxenda

Clinical Trial Phase

Clinical Trial Phase for Saxenda
Clinical Trial Phase Trials
Phase 4 9
Phase 3 2
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Saxenda
Clinical Trial Phase Trials
Recruiting 11
Not yet recruiting 5
Enrolling by invitation 2
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Clinical Trial Sponsors for Saxenda

Sponsor Name

Sponsor Name for Saxenda
Sponsor Trials
Novo Nordisk A/S 10
Janssen Research & Development, LLC 1
Beth Israel Deaconess Medical Center 1
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Sponsor Type

Sponsor Type for Saxenda
Sponsor Trials
Other 22
Industry 11
NIH 1
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Dow
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