What side effects are associated with this type of intervention?

Common treatments for obesity, particularly GLP-1 receptor agonists like liraglutide and exenatide, can cause gastrointestinal side effects such as nausea, vomiting, and diarrhea. Other potential side effects include pancreatitis, gallbladder disease, and an increased risk of thyroid C-cell tumors. Injection site reactions and hypoglycemia are also possible, especially when these medications are combined with other glucose-lowering agents.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity. Liraglutide (Saxenda) is one such drug, approved for chronic weight management in adults with a BMI of 30 kg/m2 or greater, or 27 kg/m2 or greater with at least one weight-related condition. Liraglutide has shown significant weight loss benefits in clinical trials. Another GLP-1 receptor agonist, semaglutide (Wegovy), has also been approved for weight management in similar patient populations. These drugs work by mimicking the incretin hormone GLP-1, which helps regulate appetite and food intake.

What other types of research exist?

Promising alternatives to Tirzepatide for obesity treatment include: <ol> <li>Liraglutide (GLP-1 Receptor Agonist) - Shown to significantly reduce weight and improve cardiometabolic risk factors.</li> <li></li> </ol> Semaglutide (GLP-1 Receptor Agonist) - Demonstrated substantial weight loss in clinical trials and is approved for weight management. 3. Bariatric Surgery - Effective for significant and sustained weight loss, especially in patients with severe obesity or comorbid conditions like type 2 diabetes.

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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

Must not have

Change in body weight greater than 5 kg within 3 months prior to starting study

Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity

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

Pivotal Trial

Summary

This trial is testing a medication called tirzepatide to see how it helps people who are overweight or obese lose weight. The study lasts over a year, with an additional few years for those with prediabetes. Tirzepatide works by imitating natural hormones that control blood sugar and hunger. It has shown better results in weight loss compared to other treatments in patients with type 2 diabetes.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is over 27 and I have been diagnosed with a related health condition, or it is over 30.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have lost or gained more than 5 kg in the last 3 months.

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My obesity is caused by a hormonal disorder or a specific genetic condition.

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I have a history of medullary thyroid cancer or MEN-2 in my family or myself.

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I have had pancreatitis before.

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I have diabetes.

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I haven't had severe depression or psychiatric issues in the last 2 years.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 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%

Vomiting

11%

Gastroenteritis

Flatulence

Abortion induced

Abdominal pain upper

Gingivitis

Amylase increased

Lipase increased

Abdominal pain

Injection site reaction

Menstruation irregular

Hepatic function abnormal

Hyperuricaemia

Uterine polyp

Vaginal infection

Dizziness

Hand fracture

Supraventricular tachycardia

Hiccups

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

10 mg Tirzepatide

15 mg Tirzepatide

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~7520

0 / 7Eligibility criteria met

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

Tirzepatide, a dual GIP and GLP-1 receptor agonist, works by mimicking the effects of incretin hormones, which are involved in the regulation of glucose and appetite. By activating both GIP and GLP-1 receptors, Tirzepatide enhances insulin secretion, suppresses glucagon release, slows gastric emptying, and reduces appetite, leading to significant weight loss and improved glycemic control. This dual action is particularly beneficial for obesity patients as it addresses multiple pathways involved in weight gain and metabolic dysfunction, offering a comprehensive approach to treatment.