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| ID | Type | Description | Link |
|---|---|---|---|
| I8F-MC-GPGU | Other Identifier | Eli Lilly and Company |
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This is a study of tirzepatide in participants with obesity. The main purpose is to learn more about how tirzepatide affects the number of calories participants burn and the amount of food they eat. The study lasted for 28 weeks and will include about 21 visits to the study center.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo once weekly (QW) by Subcutaneous (SC) injection. |
|
| 15 Milligram (mg) Tirzepatide | Experimental | Participants received 15 mg of tirzepatide QW by SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tirzepatide | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR) | SMR was measured using whole-room indirect calorimetry (respiratory chamber). Change from Baseline to Week 18 in SMR was evaluated. Least square (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables. | Baseline, Week 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal | Ad libitum lunch and dinner were provided. The sum of the caloric breakdown (carbohydrates, protein, and fats) was calculated from the respective nutritional information of the food items. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
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| Label | URL |
|---|---|
| A Study to Measure Food and Calorie Consumption in Very Overweight Participants Using Tirzepatide | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants received placebo once weekly (QW) by Subcutaneous (SC) injection. |
| FG001 | 15 Milligram (mg) Tirzepatide | Participants received 15 mg of tirzepatide QW by SC injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo QW by SC injection. |
| BG001 | 15 mg Tirzepatide | Participants received 15 mg of tirzepatide QW by SC injection. |
| 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 | Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR) | SMR was measured using whole-room indirect calorimetry (respiratory chamber). Change from Baseline to Week 18 in SMR was evaluated. Least square (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables. | All randomized participants who received at least one dose of study drug and had evaluable data for SMR. | Posted | Least Squares Mean | Standard Error | kilocalories per day (kcal/day) | Baseline, Week 18 |
|
Baseline Through End of Safety Follow-up (Up to 22 Weeks)
All randomized participants who received at least one dose of study drug, regardless of whether they completed all protocol requirements. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly. Frequency threshold for reporting other (not including serious) adverse event is greater than or equal to (≥) 5% in any of the treatment groups.
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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 | Placebo | Participants received placebo once weekly by SC injection. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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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 2, 2021 | May 24, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 14, 2022 | May 23, 2023 | SAP_001.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 |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Placebo | Drug | Administered SC |
|
| Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE) | 24 hour energy expenditure was measured in a respiratory chamber. LS mean was determined by ANCOVA model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ) | Respiratory quotient was calculated as the ratio of carbon dioxide production to oxygen consumption as measured in a metabolic chamber for 24 continuous hours. Ratio of total carbon dioxide production (VCO2)/total oxygen consumption (VO2), from baseline to Week 18 was evaluated. 24-hour RQ = total VCO2 [Liter/24hour] / total VO2 [Liter/24hour]. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Sleep RQ | Sleep RQ is defined as the ratio of VCO2 to VO2 during sleep time points. Change from baseline to Week 18 in sleep RQ is presented. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Duration of Periods With RQ<0.80 | RQ<0.80 is defined as the cut point for high lipid oxidation of RQ; lipid oxidation will be calculated and corrected for protein oxidation; the total number of minutes with RQ <0.80, termed "lipid oxidation duration," during each 23-hour measurement period will be recorded; protein oxidation will be determined from urine nitrogen that will be collected during 2 periods for each calorimeter day. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation | Change from Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation is presented.
Adjusted oxidation is calculated using the formula, Adjusted oxidation rate (g/day) = oxidation rate (g/day) / 24-hour Energy Expenditure) x 1000 (kcal/day). LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Body Weight (BW) | Change from baseline in BW through Week 18 in participants were presented. LS mean was determined by mixed measures repeated model (MMRM) model with Baseline, Treatment, Time, Treatment*Time, Participant and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Body Fat-Free Mass | Change from baseline to Week 18 in body fat free mass is presented. Body fat free mass was measured using dual energy X-ray absorptiometry (DXA) measurements. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Body Fat Mass | Change from baseline to Week 18 in body fat mass is presented. Body fat mass was measured using DXA measurements. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Percentage of Body Fat Mass | The total body fat mass was measured in kilograms (kg) using DXA scanning. Change from baseline to week 18 in percentage of body fat mass is reported. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Lipid Metabolism Parameters | Change in Lipid Metabolism Parameters from baseline (week 0) to week 18 is evaluated. Triglyceride, Very low density lipoprotein (VLDL), High density lipoprotein (HDL) cholesterol and free fatty acids values were reported. Results below presents Area under the Curve (AUC) during standardized mixed-meal tolerance test (sMMTT). LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Fasting Insulin Resistance | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a test that uses a simultaneous fasting blood glucose test and fasting insulin test to accurately estimate the degree of insulin resistance (IR) and β-cell function (the cells of the pancreas that produce insulin). HOMA-IR= [Fasting glucose (mmol/L) x (fasting insulin (picomoles per liter {pmol/L})/6)] / 22.5. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 during standardized mixed meal tolerance test |
| Change From Baseline to Week 18 in Postprandial Insulin Sensitivity | Insulin sensitivity was measured from insulin and glucose levels obtained following standard meal challenge using a modification of the Matsuda index. This was calculated based on data obtained from a 75 g oral glucose tolerance test, as follows: 10,000 divided by the square root of {(fasting glucose X fasting insulin) (total area under the glucose response curve (AUC) 0-4hr)) X total insulin AUC(0-4hr )}. A Matsuda index of <2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. Stumvoll and oral glucose insulin sensitivity indexes were also used for measuring the insulin Sensitivity. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT | Total AUC from time zero to 4 hours after start of the meal [AUC0-4 hours]) during sMMTT was evaluated. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | Baseline, Week 18 |
| Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c) | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was determined by ANCOVA model with Baseline, Treatment, Time, Treatment*Time, Participant and Random Error as variables. | Baseline, Week 18 |
| Physician Decision |
|
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
Participants received 15 mg of tirzepatide QW by SC injection. |
|
|
|
| Secondary | Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal | Ad libitum lunch and dinner were provided. The sum of the caloric breakdown (carbohydrates, protein, and fats) was calculated from the respective nutritional information of the food items. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and had evaluable data for food Intake during ad libitum meal. | Posted | Least Squares Mean | Standard Error | kilocalories (kcal) | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE) | 24 hour energy expenditure was measured in a respiratory chamber. LS mean was determined by ANCOVA model with Baseline, Treatment, Change from Baseline to Week 18 in Fat-Free Mass, Change from baseline to Week 18 in Fat Mass and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for 24-hour EE. | Posted | Least Squares Mean | Standard Error | kcal/day | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ) | Respiratory quotient was calculated as the ratio of carbon dioxide production to oxygen consumption as measured in a metabolic chamber for 24 continuous hours. Ratio of total carbon dioxide production (VCO2)/total oxygen consumption (VO2), from baseline to Week 18 was evaluated. 24-hour RQ = total VCO2 [Liter/24hour] / total VO2 [Liter/24hour]. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for 24-hour RQ. | Posted | Least Squares Mean | Standard Error | Ratio | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Sleep RQ | Sleep RQ is defined as the ratio of VCO2 to VO2 during sleep time points. Change from baseline to Week 18 in sleep RQ is presented. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for sleep RQ. | Posted | Least Squares Mean | Standard Error | ratio | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Duration of Periods With RQ<0.80 | RQ<0.80 is defined as the cut point for high lipid oxidation of RQ; lipid oxidation will be calculated and corrected for protein oxidation; the total number of minutes with RQ <0.80, termed "lipid oxidation duration," during each 23-hour measurement period will be recorded; protein oxidation will be determined from urine nitrogen that will be collected during 2 periods for each calorimeter day. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for duration of periods with RQ<0.80. | Posted | Least Squares Mean | Standard Error | minute | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation | Change from Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation is presented.
Adjusted oxidation is calculated using the formula, Adjusted oxidation rate (g/day) = oxidation rate (g/day) / 24-hour Energy Expenditure) x 1000 (kcal/day). LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for fat, protein, and carbohydrate oxidation. | Posted | Least Squares Mean | Standard Error | gram/day | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Body Weight (BW) | Change from baseline in BW through Week 18 in participants were presented. LS mean was determined by mixed measures repeated model (MMRM) model with Baseline, Treatment, Time, Treatment*Time, Participant and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for body weight. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Body Fat-Free Mass | Change from baseline to Week 18 in body fat free mass is presented. Body fat free mass was measured using dual energy X-ray absorptiometry (DXA) measurements. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for body fat-free mass. | Posted | Least Squares Mean | Standard Error | kg | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Body Fat Mass | Change from baseline to Week 18 in body fat mass is presented. Body fat mass was measured using DXA measurements. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for body fat mass. | Posted | Least Squares Mean | Standard Error | kg | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Percentage of Body Fat Mass | The total body fat mass was measured in kilograms (kg) using DXA scanning. Change from baseline to week 18 in percentage of body fat mass is reported. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for percentage of body fat mass. | Posted | Least Squares Mean | Standard Error | Percentage | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Lipid Metabolism Parameters | Change in Lipid Metabolism Parameters from baseline (week 0) to week 18 is evaluated. Triglyceride, Very low density lipoprotein (VLDL), High density lipoprotein (HDL) cholesterol and free fatty acids values were reported. Results below presents Area under the Curve (AUC) during standardized mixed-meal tolerance test (sMMTT). LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable data for lipid metabolism parameters. | Posted | Least Squares Mean | Standard Error | millimole hour per liter (mmol.h/L) | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Fasting Insulin Resistance | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a test that uses a simultaneous fasting blood glucose test and fasting insulin test to accurately estimate the degree of insulin resistance (IR) and β-cell function (the cells of the pancreas that produce insulin). HOMA-IR= [Fasting glucose (mmol/L) x (fasting insulin (picomoles per liter {pmol/L})/6)] / 22.5. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and who had evaluable HOMA-IR data. | Posted | Least Squares Mean | Standard Error | index | Baseline, Week 18 during standardized mixed meal tolerance test |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Postprandial Insulin Sensitivity | Insulin sensitivity was measured from insulin and glucose levels obtained following standard meal challenge using a modification of the Matsuda index. This was calculated based on data obtained from a 75 g oral glucose tolerance test, as follows: 10,000 divided by the square root of {(fasting glucose X fasting insulin) (total area under the glucose response curve (AUC) 0-4hr)) X total insulin AUC(0-4hr )}. A Matsuda index of <2.5 indicates whole body insulin resistance. A lower Matsuda Index indicates the worst disease state. An increase in the Matsuda Index indicates an improvement in insulin sensitivity (best). A positive change from Baseline indicates improvement and a negative change from Baseline indicates a worsening. Stumvoll and oral glucose insulin sensitivity indexes were also used for measuring the insulin Sensitivity. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and had evaluable data for matsuda index. | Posted | Least Squares Mean | Standard Deviation | index | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT | Total AUC from time zero to 4 hours after start of the meal [AUC0-4 hours]) during sMMTT was evaluated. LS mean was determined by ANCOVA model with Baseline, Treatment and Random Error as variables. | All randomized participants who received at least one dose of study drug and had evaluable data for postmeal total glucose AUC during sMMTT. | Posted | Least Squares Mean | Standard Error | millimolar.hour per liter (mmol.h/L) | Baseline, Week 18 |
|
|
|
|
| Secondary | Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c) | HbA1c is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. LS mean was determined by ANCOVA model with Baseline, Treatment, Time, Treatment*Time, Participant and Random Error as variables. | All randomized participants who received at least one dose of study drug and had evaluable data for HbA1c. | Posted | Least Squares Mean | Standard Error | percentage of glycosylated hemoglobin | Baseline, Week 18 |
|
|
|
|
| 28 |
| 0 |
| 28 |
| 19 |
| 28 |
| EG001 | 15 mg Tirzepatide | Participants received 15 mg of tirzepatide once weekly by subcutaneous injection. | 0 | 27 | 1 | 27 | 22 | 27 |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
|
| Corona virus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
| Adjusted carbohydrate oxidation |
|
| <0.0001 |
| LS Mean difference |
| 14.48 |
| 2-Sided |
| 95 |
| 8.02 |
| 20.93 |
| Superiority |
| Adjusted carbohydrate oxidation | ANCOVA | 0.0001 | LS Mean difference | -26.64 | 2-Sided | 95 | -39.46 | -13.83 | Superiority |
| HDL cholesterol |
|
| Free fatty acid |
|
| <0.0001 |
| LS Mean difference |
| -0.84 |
| 2-Sided |
| 95 |
| -1.19 |
| -0.48 |
| Superiority |
| For HDL | ANCOVA | 0.0436 | LS Mean difference | -0.53 | 2-Sided | 95 | -1.05 | -0.02 | Superiority |
| For Free fatty acid | ANCOVA | 0.0002 | LS Mean Difference | 0.45 | 2-Sided | 95 | 0.23 | 0.66 | Superiority |