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Glucagon-Like Peptide-1 (GLP-1) and Glucagon Receptor Agonist
Tirzepatide for Obesity (SURMOUNT-MMO Trial)
Verified Trial
Phase 3
Recruiting
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
individuals ≥40 years of age with established cardiovascular disease (CVD).
Coronary artery disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
SURMOUNT-MMO Trial Summary
This trial will look at whether tirzepatide can reduce obesity-related health problems and death in adults.
Who is the study for?
Adults with obesity are eligible, specifically those ≥40 years old with cardiovascular disease or older adults with multiple CV risk factors. Participants must have a BMI of ≥27 kg/m² but cannot have diabetes, recent serious heart conditions, pancreatitis, certain cancers in the last 5 years, or significant liver disease.Check my eligibility
What is being tested?
The trial is testing Tirzepatide's effectiveness in reducing health problems and death rates among obese adults compared to a placebo. It aims to provide more evidence for Tirzepatide as a beneficial treatment for this group.See study design
What are the potential side effects?
While not specified here, common side effects of weight loss drugs like Tirzepatide may include gastrointestinal issues (nausea, diarrhea), low blood sugar levels if diabetic medications are also being taken, and potential thyroid tumors.
SURMOUNT-MMO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 or older with a diagnosed heart condition.
Select...
I have been diagnosed with coronary artery disease.
Select...
I have a brain blood vessel condition.
SURMOUNT-MMO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)
Secondary outcome measures
Change from Baseline Diastolic Blood Pressure (DBP) (mmHg)
Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)
Kidney Failure, Chronic
+15 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-MMO Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive tirzepatide matched placebo.
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
2,620 Previous Clinical Trials
3,201,599 Total Patients Enrolled
55 Trials studying Obesity
36,219 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 40 with heart disease or at high risk due to my age and health factors.I am 40 or older with a diagnosed heart condition.I have severe stomach emptying issues or have had/planning weight loss surgery (not including liposuction or tummy tuck).I have a history of medullary thyroid cancer or MEN2 in my family or myself.I am over 40 with heart disease or have risk factors for it.I have type 1 or type 2 diabetes, or I've had ketoacidosis or a severe diabetic coma.I have hepatitis or another liver disease, or my liver tests are high.I have a brain blood vessel condition.I am a woman over 70 or a man over 65 with at least 2 risk factors.You have a higher body weight compared to what is considered healthy for your height.I have a history of pancreatitis.I have had cancer or a tumor in the last 5 years.I have had a heart attack, stroke, or a procedure to improve blood flow in the last 3 months.You have a body mass index (BMI) of 27.0 or higher.I'm sorry, but the criterion you provided is incomplete. Can you please provide the complete criterion?I have peripheral arterial disease or risk factors for heart disease.You weigh more than what is considered healthy for your height (BMI of 27 or higher).I have been diagnosed with coronary artery disease.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: 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: NCT05556512 — 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 any documented cases of severe adverse reactions to Tirzepatide?
"There is some efficacy data from Phase 3 trials to support Tirzepatide's safety, which our team has estimated to be a 3 on a scale of 1-3."
Answered by AI
Who else is applying?
What state do they live in?
New Jersey
Pennsylvania
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
Alliance for Multispecialty Research
Elite Clinical Studies, LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
2
1
3+
0
Why did patients apply to this trial?
Want to be healthier. I hoping trail works. I need to lose weight. Too fat to do anything.
PatientReceived 1 prior treatment
Because I want to help.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
Where is the trial? When does it start? how long is the study? How long is this trial?
PatientReceived no prior treatments
Is there a compensation?
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Chase Medical Research, LLC: < 24 hours
- Tandem Clinical Research, Marrero: < 24 hours
- Heritage Valley Medical Group, Inc.: < 24 hours
Typically responds via
Phone Call
Average response time
- < 2 Days
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