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

Tirzepatide for Obesity (SURMOUNT-5 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 72
Awards & highlights

SURMOUNT-5 Trial Summary

This trial will assess the effectiveness & safety of a new drug for adults with obesity & related conditions, lasting 78 weeks.

Who is the study for?
This trial is for adults with obesity or overweight who have unsuccessfully tried to lose weight through diet and have related health issues like high blood pressure, but not diabetes. Participants should have a BMI of ≥30 kg/m², or ≥27 kg/m² with conditions such as hypertension. Those with recent significant weight changes, severe psychiatric disorders, certain endocrine disorders, pancreatitis, or a family history of specific thyroid cancers cannot join.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of two drugs: Tirzepatide and Semaglutide in individuals without Type 2 Diabetes but who are obese or overweight with related health problems. The trial will run for about 74 weeks to see which drug is better at helping participants lose weight.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea, possible inflammation of the pancreas (pancreatitis), allergic reactions, changes in heart rate or mood swings. Each person's experience can vary.

SURMOUNT-5 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 72
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 72 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 Baseline in Body Weight
Secondary outcome measures
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Waist Circumference in Centimeter (cm)
Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg
+5 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-5 Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
Group II: SemaglutideActive Control1 Intervention
Participants will receive semaglutide SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7590

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,613 Previous Clinical Trials
3,200,229 Total Patients Enrolled
53 Trials studying Obesity
40,128 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
404,552 Total Patients Enrolled
36 Trials studying Obesity
19,847 Patients Enrolled for Obesity

Media Library

Semaglutide 2.4 mg (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05822830 — Phase 3
Obesity Research Study Groups: Semaglutide, Tirzepatide
Obesity Clinical Trial 2023: Semaglutide 2.4 mg Highlights & Side Effects. Trial Name: NCT05822830 — Phase 3
Semaglutide 2.4 mg (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05822830 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05822830 — Phase 3

Frequently Asked Questions

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

Has Tirzepatide been ratified by the FDA?

"The safety of tirzepatide was rated a 3 on our scale due to the multiple rounds of evidence confirming its efficacy and prior clinical data backing up its security."

Answered by AI

How many healthcare facilities are conducting this investigation?

"This clinical trial is hosting recruitment at 61 different locations, including Pelham, Santa Ana and Spring Valley. To reduce the burden of travel for study participants it is recommended to select the closest site possible."

Answered by AI

Are there any vacancies still available for prospective participants in this trial?

"The data hosted on clinicaltrials.gov reveals that this study is not currently seeking participants, which was first unveiled on April 28th 2023 and has since been edited as recently as April 10th of the same year. Nonetheless, there are still over a thousand trials actively enrolling patients at present."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Missouri
Texas
Other
What site did they apply to?
Cahaba Research - Pelham
Palm Research Center Tenaya
The University of Texas Health Science Center at Houston
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0

Why did patients apply to this trial?

I need help losing weight. Again, I've been on every diet possible,. I've tried HCG, Phen-Fen, dieting and nothing worked.
PatientReceived no prior treatments
I’ve tried weightloss pills that haven’t worked for me. I want to lose weight and my diet and exercise is not working.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

How long does screening visit take? How often do screenings take place? How often and long are screenings during the trial?
PatientReceived 1 prior treatment
How often would one have to come to the site for visits? Which medication and how much is the compensation for the study?
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
2023. "A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05822830.
All > Fargo > Overweight
~233 spots leftby Nov 2024
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