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

Tirzepatide for Obesity (SURMOUNT-4 Trial)

Phase 3
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 week 88
Awards & highlights

SURMOUNT-4 Trial Summary

This trial is testing tirzepatide to see if it can help people with obesity or overweight maintain weight loss. The study will last about 2 years, with participants taking the drug or a placebo.

Eligible Conditions
  • Obesity

SURMOUNT-4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 88
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 88 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change from Randomization (Week 36) in Body Weight
Secondary outcome measures
Change from Baseline in BMI
Change from Baseline in Body Weight
Change from Baseline in DBP
+36 more

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

SURMOUNT-4 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TirzepatideExperimental Treatment1 Intervention
Tirzepatide administered subcutaneously (SC)
Group II: PlaceboPlacebo Group1 Intervention
Placebo administered SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,615 Previous Clinical Trials
3,200,275 Total Patients Enrolled
53 Trials studying Obesity
40,045 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,469 Total Patients Enrolled
36 Trials studying Obesity
19,764 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.

What is the Tirzepatide drug's official status?

"There is existing clinical data that suggests tirzepatide is safe, so it received a score of 3."

Answered by AI

At how many different medical facilities can people participate in this research project?

"Currently, the trial is being conducted in 12 locations, which are spread throughout Troy, Jacksonville, Chapel Hill and other cities. If you are worried about travel, it may be best to select a location that is close to you."

Answered by AI

Have other similar trials been conducted in the past?

"Eli Lilly and Company sponsored the first Tirzepatide study in 2019, which completed Phase 2 drug approval with 196 patients. Since then, 11 active trials have been conducted across 631 cities and 31 countries. A total of 18253 trials have been completed since 2019."

Answered by AI

Does the scientific community have a history of research on Tirzepatide?

"As of now, there are 11 different ongoing clinical trials studying Tirzepatide. Out of these 11 trials, 9 of them are in Phase 3. Additionally, while a few of the Tirzepatide trials are happening in Bangalore, Karnataka, there are a total of 1675 locations running clinical trials for Tirzepatide."

Answered by AI

Are we still enrolling individuals for this research project?

"This study is no longer recruiting patients. According to the information on clinicaltrials.gov, it was first posted on 3/29/2021 and last edited on 10/5/2021. If you are looking for other studies, there are 1262 trials related to obesity and 11 studies related to Tirzepatide that are currently recruiting participants."

Answered by AI

Who else is applying?

What state do they live in?
Florida
North Carolina
Texas
Other
How old are they?
< 18
65+
18 - 65
What site did they apply to?
Healthcare Research Network - Chicago
Clinical Trials of Texas, Inc.
North Texas Endocrine Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
3+
1

Why did patients apply to this trial?

phetermine didnt work for me and looking to try something new. I had tried every type of diet that you can think of, but of course the weight comes back even faster.
PatientReceived 1 prior treatment
I have tried diets, intermittent fasting, keto, Noom, move program and plenity. The extra weight is causing many problems and I would like to find something that helps.
PatientReceived 1 prior treatment
I no have tried every fad diet… and spoke with my doctor…but all with no luck. I’m not able to walk or run or jump for exercise due to the neuropathy in my feet. It makes it nearly impossible to exercise.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long do screenings take?
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss
2021. "A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04660643.
~196 spots leftby Apr 2025
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