A Study of Tirzepatide in Overweight and Very Overweight Participants

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 28, 2022

Interventions

  • Drug: Tirzepatide
    • Administered SC.
  • Drug: Placebo
    • Administered SC.
  • Drug: Liraglutide
    • Administered SC.

Arms, Groups and Cohorts

  • Experimental: Tirzepatide
    • Tirzepatide administered subcutaneously (SC).
  • Placebo Comparator: Placebo
    • Placebo administered SC.
  • Active Comparator: Liraglutide
    • Liraglutide administered SC.

Clinical Trial Outcome Measures

Primary Measures

  • Change from Baseline in Energy Intake (kilocalories per day)
    • Time Frame: Baseline, Week 3
    • Energy intake (kcal/day) will be assessed by ad libitum food intake test

Secondary Measures

  • Change from Baseline in Blood Oxygenation Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation to Images of High-Fat Foods during the Fasting and Postprandial States in the Brain Reward Areas
    • Time Frame: Baseline, Week 3
  • Change from Baseline in Fasting and Postprandial Appetite Visual Analog Scale (VAS)
    • Time Frame: Baseline, Week 3
    • The VAS scales will be analyzed as continuous variables on the 0-100 scale for individual components. Overall appetite score will be calculated as the average of the four individual scores (satiety + fullness + [100-prospective food consumption] + [100-hunger]/4). The higher overall appetite score indicates less appetite and the lower score indicates more appetite.

Participating in This Clinical Trial

Inclusion Criteria

  • Have stable body weight for the past 1 month prior to screening
  • Have a body mass index (BMI) between 27 to 45 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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), Study Director, Eli Lilly and Company
  • Overall Contact(s)
    • This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or, 1-317-615-4559, ClinicalTrials.gov@lilly.com

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