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

Tirzepatide for Obesity (SURMOUNT-3 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

Pivotal Trial

Summary

This trial is testing tirzepatide, a medication that may help people with obesity maintain or lose weight after lifestyle changes. It targets those who have already tried intensive lifestyle modifications. The medication works by controlling blood sugar and appetite. Tirzepatide has shown significant efficacy in weight loss and glucose control in patients with type 2 diabetes and obesity.

Eligible Conditions

Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 72

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

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

Primary study objectives

Percent Change From Baseline in Body Weight

Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction

Secondary study objectives

Change From Baseline in Body Mass Index (BMI)

Change From Baseline in Body Weight

Change From Baseline in Diastolic Blood Pressure (DBP)

+17 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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TirzepatideExperimental Treatment1 Intervention

Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.

Group II: PlaceboPlacebo Group1 Intervention

Participants received matching placebo SC once weekly (QW).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~7520

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