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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
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This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are experiencing weight regain as well as the safety of liraglutide in this patient population.
The specific aims of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxenda | Experimental | Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day |
|
| Placebo | Placebo Comparator | Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxenda | Drug | Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test | CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly Lofton, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Medical Center | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saxenda | Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day |
| FG001 | Placebo | Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Placebo: Subcutaneous Saline Solution |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Saxenda | Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day |
| BG001 | Placebo |
| 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 | Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test | CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification | Posted | Number | percentage of participants | 12 Months |
|
1 year
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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 | Saxenda | Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly F. Lofton, MD | NYU Langone Health - Weight Management Program | (212) 263-3166 | Holly.Lofton@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 11, 2019 | Feb 24, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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Randomization will be 2:1 (drug:placebo) with stratification by gender and percent post-operative TBWL (25%, 25 - 49.9%).
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| Placebo | Drug | Subcutaneous Saline Solution |
|
| Adverse Event |
|
| Terminated |
|
Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Placebo: Subcutaneous Saline Solution |
| 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 |
|
| Region of Enrollment | Number | participants |
|
|
|
| 0 |
| 89 |
| 4 |
| 89 |
| 40 |
| 89 |
| EG001 | Placebo | Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Placebo: Subcutaneous Saline Solution | 0 | 43 | 6 | 43 | 26 | 43 |
| CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
|
| HEPATITIS A | Infections and infestations | Non-systematic Assessment |
|
| INTERNAL HERNIA | Gastrointestinal disorders | Non-systematic Assessment |
|
| PAPILLARY THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | Non-systematic Assessment |
|
| SURGERY | Surgical and medical procedures | Non-systematic Assessment |
|
| SYNCOPE | General disorders | Non-systematic Assessment |
|
| ABNORMAL KIDNEY FUNCTION | Renal and urinary disorders | Non-systematic Assessment |
|
| ACID REFLUX | Gastrointestinal disorders | Non-systematic Assessment |
|
| AGGRAVATED GERD | Gastrointestinal disorders | Non-systematic Assessment |
|
| ANXIETY | Psychiatric disorders | Non-systematic Assessment |
|
| BAD MOUTH TASTE | General disorders | Non-systematic Assessment |
|
| BURNING SENSATION AT INJECTION S | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| CHEST TIGHTNESS | General disorders | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
|
| DECREASED APPETITE | General disorders | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| DIZZINESS | General disorders | Non-systematic Assessment |
|
| DRY MOUTH | General disorders | Non-systematic Assessment |
|
| ED VISIT | Surgical and medical procedures | Non-systematic Assessment |
|
| EXCESSIVE PERSPIRATION | General disorders | Non-systematic Assessment |
|
| FATIGUE | General disorders | Non-systematic Assessment |
|
| FLATULENCE | Gastrointestinal disorders | Non-systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | Non-systematic Assessment |
|
| GOUT FLARE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| HAIR LOSS | General disorders | Non-systematic Assessment |
|
| HEADACHE | General disorders | Non-systematic Assessment |
|
| HIGH BLOOD PRESSURE | Cardiac disorders | Non-systematic Assessment |
|
| HIGH ENERGY | General disorders | Non-systematic Assessment |
|
| INCREASED ALCOHOL CONSUMPTION | General disorders | Non-systematic Assessment |
|
| INCREASED CREATININE (AGGRAVATED) | Renal and urinary disorders | Non-systematic Assessment |
|
| INJECTION SITE SWELLING | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| INSOMNIA | General disorders | Non-systematic Assessment |
|
| LACK OF APPETITE | General disorders | Non-systematic Assessment |
|
| MOOD CHANGES - INCREASED IRRITABI | Psychiatric disorders | Non-systematic Assessment |
|
| MUSCLE SPASM | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| NIGHTTIME BINGE EATING | Psychiatric disorders | Non-systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | Non-systematic Assessment |
|
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| REDNESS AT INJECTION SITE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| SENSITIVITY TO COLD (LIGHTHEADNES | General disorders | Non-systematic Assessment |
|
| SHORTNESS OF BREATH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| STOMACH PAIN | Gastrointestinal disorders | Non-systematic Assessment |
|
| SWOLLEN SALIVARY GLAND | Endocrine disorders | Non-systematic Assessment |
|
| SWOLLEN THYROID GLAND | Endocrine disorders | Non-systematic Assessment |
|
| TIGHT CHEST | General disorders | Non-systematic Assessment |
|
| URGENCY TO URINATE | Renal and urinary disorders | Non-systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |