Clinical trial NCT04081337: A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR)
timeFrame: Baseline, Week 18
Secondary outcomes:
measure: Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE)
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ)
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Sleep RQ
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Duration of Periods With RQ<0.80
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Body Weight (BW)
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Body Fat-Free Mass
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Body Fat Mass
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Percentage of Body Fat Mass
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Lipid Metabolism Parameters
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Fasting Insulin Resistance
timeFrame: Baseline, Week 18 during standardized mixed meal tolerance test
measure: Change From Baseline to Week 18 in Postprandial Insulin Sensitivity
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT
timeFrame: Baseline, Week 18
measure: Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 18
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: