A Study of Tirzepatide in Overweight and Very Overweight Participants
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
2 other identifiers
interventional
114
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 obesity
Started Aug 2020
Typical duration for phase_1 obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2022
CompletedResults Posted
Study results publicly available
May 22, 2024
CompletedMay 22, 2024
May 1, 2024
2.3 years
March 16, 2020
December 12, 2023
May 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3
Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.
Baseline, Week 3
Secondary Outcomes (2)
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
Baseline, Week 3
Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score
Baseline, Week 3
Study Arms (3)
Tirzepatide
EXPERIMENTALParticipants received tirzepatide 5 milligrams (mg) once a week (QW) for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the subcutaneous (SC) tissue of the abdominal wall.
Placebo
PLACEBO COMPARATORParticipants received placebo administered into the SC tissue of the abdominal wall.
Liraglutide
ACTIVE COMPARATORParticipants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg once daily (QD) for week 1 followed by 1.2 mg QD for week 2, 1.8 mg QD for week 3, 2.4 mg QD for Week 4 followed by 3 mg QD starting in Week 5 and maintained for 10 days administered into the SC tissue of the abdominal wall.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Related Publications (1)
Martin CK, Carmichael OT, Carnell S, Considine RV, Kareken DA, Dydak U, Mattes RD, Scott D, Shcherbinin S, Nishiyama H, Knights A, Urva S, Biernat L, Pratt E, Haupt A, Mintun M, Otero Svaldi D, Milicevic Z, Coskun T. Tirzepatide on ingestive behavior in adults with overweight or obesity: a randomized 6-week phase 1 trial. Nat Med. 2025 Sep;31(9):3141-3150. doi: 10.1038/s41591-025-03774-9. Epub 2025 Jun 24.
PMID: 40555748DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Tirzepatide and placebo dosing are double-blind. Liraglutide dosing is open label.
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2020
First Posted
March 17, 2020
Study Start
August 24, 2020
Primary Completion
December 16, 2022
Study Completion
December 16, 2022
Last Updated
May 22, 2024
Results First Posted
May 22, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share