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

Tirzepatide for Obesity (SURMOUNT-4 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 randomization (week 36), week 88

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial tested tirzepatide, a weight-loss medication, in people who are obese or overweight. The goal was to see how well it helps maintain weight loss. Participants first took tirzepatide, then either continued it or switched to another treatment. The study lasted several years. Tirzepatide is a novel medication effective in treating obesity, showing significant weight loss.

Eligible Conditions

Obesity

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization (week 36), week 88

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization (week 36), week 88

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization (week 36), week 88 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 Randomization in Body Weight at Week 88

Secondary study objectives

Change From Baseline in BMI

Change From Baseline in Body Weight

Change From Baseline in Fasting Glucose

+22 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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Tirzepatide MTDExperimental Treatment1 Intervention

Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks.

Group II: Tirzepatide (lead-in)Experimental Treatment1 Intervention

Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.

Group III: PlaceboPlacebo Group1 Intervention

Participants received weekly doses of placebo SC for 52 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

FDA approved

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