Clinical trial NCT04311411: A Study of Tirzepatide in Overweight and Very Overweight Participants
Official title: Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Overweight
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-03-17
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to measure the effect of tirzepatide on food intake in participants who are overweight or very overweight. The study will also use imaging to learn more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on appetite will also be studied. The study will last up to about four months and will include up to 14 visits to the study center.


Eligibility criteria: Inclusion Criteria:

* Have stable body weight for the past 1 month prior to screening
* Have a body mass index (BMI) between 27 to 50 kilograms per meter squared (kg/m²), inclusive at screening
* Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
* Women must not be pregnant or breastfeeding

Exclusion Criteria:

* Have undergone or plan to undergo gastric bypass or bariatric surgery
* Have claustrophobia or have ferromagnetic implants that can interfere with completion of fMRI measurements
* Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
* Unwilling to comply with smoking and alcohol restrictions during the study
* Have received prescription drugs or over the counter drugs that promote weight loss in the past 6 months prior to screening
* Have a diagnosis of type 2 diabetes

Primary outcomes:
measure: Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3
timeFrame: Baseline, Week 3
Secondary outcomes:
measure: Change From Baseline in Blood Oxygen Level-dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signals in Response to Images of Highly Palatable Food Relative to Nonfood Item During Fasting State in the 5 Brain Reward Areas
timeFrame: Baseline, Week 3
measure: Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score
timeFrame: Baseline, Week 3
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
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: