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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
Must not have
Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma
Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery. Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 or older with a diagnosed heart condition.
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I have been diagnosed with coronary artery disease.
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I have a brain blood vessel condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have type 1 or type 2 diabetes, or I've had ketoacidosis or a severe diabetic coma.
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I have severe stomach emptying issues or have had/planning weight loss surgery (not including liposuction or tummy tuck).
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I have a history of pancreatitis.
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I have a history of medullary thyroid cancer or MEN2 in my family or myself.
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I have hepatitis or another liver disease, or my liver tests are high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 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

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
~5560

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for obesity, particularly those similar to Tirzepatide, involve the use of dual GIP and GLP-1 receptor agonists. These medications work by mimicking the incretin hormones, which are released after eating and help regulate insulin secretion, slow gastric emptying, and reduce appetite. By enhancing these natural processes, these treatments can lead to significant weight loss and improved metabolic health. This is crucial for obesity patients as it addresses both weight reduction and the associated comorbidities, such as type 2 diabetes and cardiovascular risks, thereby improving overall health outcomes.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,203,110 Total Patients Enrolled
57 Trials studying Obesity
36,825 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company

Media Library

Tirzepatide (Glucagon-Like Peptide-1 (GLP-1) and Glucagon Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05556512 — Phase 3
Obesity Research Study Groups: Placebo, Tirzepatide
Obesity Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT05556512 — Phase 3
Tirzepatide (Glucagon-Like Peptide-1 (GLP-1) and Glucagon Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05556512 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05556512 — Phase 3
~9661 spots leftby Oct 2027