Phase 1
Completed N=55
A Study to Measure Energy Expenditure and Food Intake in Participants With Obesity Using Tirzepatide
Source: ClinicalTrials.gov NCT04081337 ↗Enrolled (actual)
55
Serious AEs
1.8%
Results posted
Feb 2024
Primary outcomePrimary: Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR) — -154.36; -134.68 kilocalories per day (kcal/day) — p=0.5733
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 18 in Sleep Metabolic Rate (SMR) |
-154.36; -134.68 | 0.5733 |
| SECONDARY Change From Baseline to Week 18 in Food Intake During Ad Libitum Meal |
-58.57; -914.51 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 18 in 24-hour Energy Expenditure (EE) |
-296.85; -300.07 | 0.9481 |
| SECONDARY Change From Baseline to Week 18 in 24 Hour Respiratory Quotient (RQ) |
0.005; -0.030 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 18 in Sleep RQ |
-0.001; -0,028 | 0.0031 sig |
| SECONDARY Change From Baseline to Week 18 in Duration of Periods With RQ<0.80 |
2.55; 254.44 | 0.0004 sig |
| SECONDARY Change From Baseline to Week 18 in Fat, Protein, and Carbohydrate Oxidation |
-0.14; -7.00; -1.64; 12.83; 4.23; -22.42 | 0.0005 sig |
| SECONDARY Change From Baseline to Week 18 in Body Weight (BW) |
-8.26; -16.73 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 18 in Body Fat-Free Mass |
-1.64; -5.73 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 18 in Body Fat Mass |
-6.75; -11.83 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 18 in Percentage of Body Fat Mass |
-3.12; -4.26 | 0.0304 sig |
| SECONDARY Change From Baseline to Week 18 in Lipid Metabolism Parameters |
-0.69; -2.52; -0.32; -1.16; 0.20; -0.33 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 18 in Fasting Insulin Resistance |
-0.37; -0.34 | 0.8762 |
| SECONDARY Change From Baseline to Week 18 in Postprandial Insulin Sensitivity |
1.43; 4.92 | 0.0126 sig |
| SECONDARY Change From Baseline to Week 18 in Postmeal Total Glucose AUC During sMMTT |
-1.73; -3.00 | 0.0222 sig |
| SECONDARY Change From Baseline to Week 18 in Hemoglobin A1c (HbA1c) |
-0.04; -0.40 | <0.0001 sig |
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)
Data sourced from ClinicalTrials.gov (NCT04081337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.