A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide

Obesity Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081337
• Other study ID #: 17092
• Secondary ID: I8F-MC-GPGU
• Status: Completed
• Phase: Phase 1
• Start date: July 9, 2020
• Est. completion date: May 26, 2022

Study information

• Verified date: May 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 26, 2022
• Est. primary completion date: May 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Have body mass index of 30 to 45 kilograms per square meter (kg/m²), inclusive

• Have a stable body weight in the past 1 month prior to screening

• Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff

Exclusion Criteria:

• Have undergone gastric bypass or bariatric surgery

• Have a diagnosis of type 2 diabetes

• Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the study drug; or of interfering with the interpretation of data

• Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening

• Have any lifetime history of a suicide attempt

• Patient Health Questionnaire-9 (PHQ-9) score of 15 or more at screening

• Positive responses to selected items on the Columbia Suicide Severity Rating Scale (C-SSRS)

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Tirzepatide
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, Week 18
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.	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.	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.	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.	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.	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.; Protein Oxidation = 6.25*[urinary nitrogen]; Fat Oxidation = 1.689*[total oxygen consumption (VO2)] - 1.689*[total carbon dioxide production (VCO2)] - 0.324*[protein oxidation]; Carbohydrate Oxidation = 4.113*[VCO2] - 2.907*[VO2] - 0.375*[protein oxidation].; 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
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.	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.	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.	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.	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.	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 ß-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
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.	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.	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.	Baseline, Week 18

External Links

•   A Study to Measure Food and Calorie Consumption in Very Overweight Participants Using Tirzepatide