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Glucagon-like peptide-1 receptor agonist
Tirzepatide for Obesity (SURMOUNT-1 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
Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
Awards & highlights
SURMOUNT-1 Trial Summary
This trial is studying tirzepatide in people who are overweight or obese. The main goal is to learn how tirzepatide affects body weight. The study has two parts: a main phase and an extension phase. The main phase will last 72 weeks (14 visits). People with prediabetes will continue in the extension for another 2 years.
Who is the study for?
This trial is for adults who've tried to lose weight through dieting without success. They must have a BMI of at least 30, or over 27 with conditions like high blood pressure or sleep apnea. People with diabetes, recent significant weight changes, certain genetic disorders related to obesity, a history of pancreatitis or severe psychiatric issues in the last two years cannot join.Check my eligibility
What is being tested?
The study tests Tirzepatide's effects on body weight in overweight and obese individuals. It includes a placebo group for comparison and has two phases: an initial phase lasting 72 weeks and an extension phase spanning another two years for participants with prediabetes.See study design
What are the potential side effects?
While not specified here, common side effects of weight loss drugs can include gastrointestinal issues such as nausea and diarrhea, headaches, increased heart rate, insomnia, dry mouth and potential allergic reactions.
SURMOUNT-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is over 27 and I have been diagnosed with a related health condition, or it is over 30.
SURMOUNT-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change From Baseline in Body Mass Index (BMI)
Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg)
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg)
+20 moreSide effects data
From 2022 Phase 3 trial • 210 Patients • NCT0502403240%
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-1 Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: 5 mg TirzepatideExperimental Treatment1 Intervention
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Group II: 15 mg TirzepatideExperimental Treatment1 Intervention
15 mg tirzepatide administered SC once a week.
Group III: 10 mg TirzepatideExperimental Treatment1 Intervention
10 mg tirzepatide administered SC once a week.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo administered SC once a week.
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
3,198,390 Total Patients Enrolled
53 Trials studying Obesity
38,289 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,344 Previous Clinical Trials
402,713 Total Patients Enrolled
36 Trials studying Obesity
18,008 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lost or gained more than 5 kg in the last 3 months.My obesity is caused by a hormonal disorder or a specific genetic condition.My BMI is over 27 and I have been diagnosed with a related health condition, or it is over 30.I have a history of medullary thyroid cancer or MEN-2 in my family or myself.You have attempted suicide in the past.I have had pancreatitis before.I have diabetes.I haven't had severe depression or psychiatric issues in the last 2 years.You have tried to lose weight through dieting before, but it didn't work.
Research Study Groups:
This trial has the following groups:- Group 1: 5 mg Tirzepatide
- Group 2: 10 mg Tirzepatide
- Group 3: Placebo
- Group 4: 15 mg Tirzepatide
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT04184622 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there other studies that have used Tirzepatide to test its effects?
"There are currently 10 Tirzepatide trials underway, 8 of which have advanced to Phase 3. Most of these clinical studies are based in Buenos Aires and California; however, there are 1529 research sites for Tirzepatide globally."
Answered by AI
Is this research the first to be conducted on this topic?
"Tirzepatide has been subjected to clinical trials since 2019. The first official trial was sponsored by Eli Lilly and Company in the same year. After the Phase 1 study involving 196 patients, Tirzepatide received drug approval for Phase 2 testing. As of now, there are 10 ongoing studies in 31 countries and 616 cities."
Answered by AI
Has the FDA given Tirzepatide the green light?
"There is Phase 3 clinical trial data available for Tirzepatide, which our analysts have used to rate the safety of this medication as a 3."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
California
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Cahaba Research
Texas Diabetes & Endocrinology, P.A.
Palm Research Center Tenaya
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
3+
0
Why did patients apply to this trial?
I need to lose weight. My BMI right at 27 . I want to loose weight. To loose some more weight.
PatientReceived no prior treatments
Need to lose weight but cant.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long is the trial? Will someone call me soon? How long do screening visits take?
PatientReceived 1 prior treatment
Are there any disqualifying factors? How long do screening visits take???
PatientReceived 2+ prior treatments
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