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Glucagon-like peptide-1 (GLP-1) receptor agonist

Tirzepatide for Obesity

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 3
Awards & highlights

Study Summary

This trial is testing the effect of tirzepatide on food intake in obese or overweight people. It will also use brain imaging to learn more about how tirzepatide affects specific parts of the brain related to appetite. The trial will last up to four months and include up to 14 visits to the study center.

Eligible Conditions
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Energy Intake (kilocalories per day)
Secondary outcome 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 State in the Brain Reward Areas
Change from Baseline in Fasting and Postprandial Appetite Visual Analog Scale (VAS)

Side effects data

From 2022 Phase 3 trial • 210 Patients • NCT05024032
40%
Diarrhoea
30%
Nausea
27%
Decreased appetite
23%
Upper respiratory tract infection
19%
Abdominal distension
11%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: TirzepatideExperimental Treatment1 Intervention
Tirzepatide administered subcutaneously (SC).
Group II: LiraglutideActive Control1 Intervention
Liraglutide administered SC.
Group III: PlaceboPlacebo Group1 Intervention
Placebo administered SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~5780

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,619 Previous Clinical Trials
3,206,485 Total Patients Enrolled
54 Trials studying Obesity
41,105 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,347 Previous Clinical Trials
405,631 Total Patients Enrolled
37 Trials studying Obesity
20,824 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this experiment still open to those wishing to participate?

"The information on clinicaltrials.gov indicates that this medical study is not presently seeking enrollees, though it was initially posted August 24th 2020 and revised October 18th 2022. However, there are 1176 other current trials requiring participants at the moment."

Answered by AI

In which locales are the findings of this trial being collected?

"This research study is being conducted across several sites, such as Pennington Biomedical Research Center in Baton Rouge, Louisiana; Indiana University School of Medicine in Indianapolis, Indiana; and Johns Hopkins University School of Medicine in Baltimore, Maryland."

Answered by AI

Are there age restrictions for participants in this investigation?

"The age criteria for eligibility in this study requires candidate to be of legal adulthood and no older than 65."

Answered by AI

Are there any previous trials that have measured the efficacy of Tirzepatide?

"Initially explored in 2012 by UBMD Pediatrics, Division of Pediatric Endocrinology, tirzepatide has seen over 18571 completed trials. Currently 44 clinical research studies are currently underway, with a significant number occurring in Baton Rouge, Louisiana."

Answered by AI

To whom is eligibility for this research being extended?

"To qualify for inclusion in this research, participants must be overweight and aged between 18-65. The trial is currently enrolling 111 individuals."

Answered by AI

How many participants are being treated in this clinical experiment?

"This trial is no longer accepting new patients. It was initially listed on August 24th 2020, and had its last edit on October 18th 2022. If you are looking for other studies involving obesity or Tirzepatide specifically, there are 1132 and 44 trials respectively that remain open to enrollment."

Answered by AI

What applications is Tirzepatide commonly utilized for?

"Tirzepatide is commonly used to manage exercise-related health issues. Additionally, this medication may provide benefits in terms of inadequate control on monotherapy, cardiovascular risk reduction, and the treatment of cardiovascular disease (CVD)."

Answered by AI

Has Tirzepatide obtained regulatory authorization from the FDA?

"As Tirzepatide is still in the early stages of clinical testing, there is insufficient data to support its safety and efficacy. Accordingly, it has been rated a 1 on our team's scale."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Rhode Island
Indiana
How old are they?
18 - 65
What site did they apply to?
Pennington Biomedical Research Center
Brown University School of Medicine
Indiana University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Tirzepatide in Overweight and Very Overweight Participants
2020. "A Study of Tirzepatide in Overweight and Very Overweight Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04311411.
~24 spots leftby Apr 2025
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