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ObesityPhase 1NCT04311411

A Study of Tirzepatide in Overweight and Very Overweight Participants

A Phase 1 study testing Tirzepatide and Liraglutide in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obesity, Overweight
What is being tested?
Tirzepatide and Liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
114 participants
Where
3 sitesUnited States
Study dates
24 Aug 2020to 16 Dec 2022
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

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

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.

Conditions
Obesity, Overweight
Being tested
Tirzepatide, Placebo, Liraglutide
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called LY3298176

    Administered SC.

  • PlaceboDrug

    Administered SC.

  • LiraglutideDrug

    Administered SC.

Study groups in NCT04311411
Study groupRoleWhat they receive
TirzepatideExperimentalParticipants 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.
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorParticipants received placebo administered into the SC tissue of the abdominal wall.
Receives: Drug: Placebo
LiraglutideActive 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.
Receives: Drug: Liraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 3

Secondary outcomes (2)

  1. 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

    Change from baseline in BOLD fMRI signals in response to images of highly palatable foods (high fat-high sugar and high fat-high carbohydrate) relative to nonfood items during the fasting state in the brain reward areas (Insula, medial frontal gyrus, superior temporal gyrus, precentral gyrus, and cingulate gyrus) at Week 3 is reported. fMRI is a functional neuroimaging procedure that uses MRI technology to measure brain activity by detecting associated changes in blood flow. When an area of the brain is in use, blood flow to that region increases. The activation in response to the processing of viewing food images in each brain reward areas was measured by the signal change in BOLD response. Least squares (LS) mean was calculated using mixed-model repeated measures (MMRM) model with covariates Baseline + Treatment + Baseline Body mass index (BMI) Stratum + Scanner Identification + Week + Treatment*Week + Participant + Random Error.

    Measured: Baseline, Week 3

  2. Change From Baseline in Fasting and Postprandial Overall Appetite Visual Analog Scale (VAS) Score

    The VAS determines the effects on appetite sensations and desire for specific foods. It consists of 8 individual questions that measure hunger, satiety, fullness, prospective food consumption, desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food. The VAS scales will be analyzed as continuous variables on the 0-100 scale for 8 individual components. Hunger, satiety, fullness, prospective food consumption are rated as 0=Not at all and 100=Extremely. Desire for sweet food, desire for salty food, desire for savory food, and desire for fatty food are rated as 0=Yes, very much and 100=No, not at all. Overall appetite score is calculated as the average of the first 4 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.

    Measured: Baseline, Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2020
  2. Study start24 Aug 2020
  3. Primary completion16 Dec 2022
  4. Study completion16 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04311411
Sponsor's protocol ID
17223
Other IDs
I8F-MC-GPHH
Status last verified
May 2024
First submitted
16 Mar 2020
Last updated
22 May 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40555748

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tirzepatide and Liraglutide in people with Obesity and Overweight, run by Eli Lilly and Company at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3 (time frame: Baseline, Week 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04311411, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.

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