Skip to content

Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of Tirzepatide in Overweight and Very Overweight Participants

NCTNCT04311411 (opens ClinicalTrials.gov in a new tab)Other id17223Other idI8F-MC-GPHH
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
114 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
24 Aug 2020
Primary completion
16 Dec 2022
Completion
16 Dec 2022
First posted
17 Mar 2020
Last update posted
22 May 2024
Conditions
Obesity · Overweight

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph 1

    A Study of Tirzepatide in Overweight and Very Overweight Participants

    NCT04311411

    24 Aug 2020 to 16 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • PlaceboDrug
  • LiraglutideDrug

Arms3

  • Experimental

    Tirzepatide

    Participants 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 comparator

    Placebo

    Participants received placebo administered into the SC tissue of the abdominal wall.

  • Active comparator

    Liraglutide

    Participants 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3

    Time frame · Baseline, Week 3

    Registry description

    Change from baseline in calorie intake in participants receiving tirzepatide or placebo at week 3 is reported.

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

    Time frame · Baseline, Week 3

    Registry description

    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.

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

    Time frame · Baseline, Week 3

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 3

Change From Baseline in Calorie Intake in Participants Receiving Tirzepatide or Placebo at Week 3

GroupValue (kilocalories (kcal))Spread
Placebo10.9549.06
Tirzepatide-523.1552.78
Secondary and other outcome results(2)
Secondary outcomeLeast squares mean· Baseline, Week 3

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

GroupValue (Arbitrary Units)Spread
Placebo-0.07390.0740
Tirzepatide-0.03010.0771
Liraglutide0.01900.0738
Secondary outcomeLeast squares mean· Baseline, Week 3

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

GroupValue (score on a scale)Spread
Placebo2.153.02
Tirzepatide22.723.30
Liraglutide8.783.11

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboParticipants received placebo administered into the SC tissue of the abdominal wall.0 / 390 / 3911 / 39
TirzepatideParticipants received tirzepatide 5 mg QW for Weeks 1 through 3 followed by tirzepatide 10 mg QW for Weeks 4 through 6 into the SC tissue of the abdominal wall.0 / 370 / 3729 / 37
LiraglutideParticipants received Liraglutide with step wise dose escalation regimen starting from 0.6 mg 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.0 / 381 / 3820 / 38

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

12 results

Tirzepatide on ingestive behavior in adults with overweight or obesity: a randomized 6-week phase 1 trial.

Martin et al. 2025Nature medicinecited by 52

PMID 40555748PMC12443625DOI 10.1038/s41591-025-03774-9PUB-40555748

CC BY12 results
Download PDFSee results (12)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.