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Glucagon-like peptide-1 (GLP-1) receptor agonist
A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program (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
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 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%
Vomiting
11%
Gastroenteritis
9%
Flatulence
9%
Abortion induced
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Abdominal pain
6%
Injection site reaction
6%
Menstruation irregular
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Vaginal infection
3%
Dizziness
1%
Hand fracture
1%
Supraventricular tachycardia
1%
Hiccups
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,678 Previous Clinical Trials
3,465,116 Total Patients Enrolled
69 Trials studying Obesity
45,982 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
427,589 Total Patients Enrolled
51 Trials studying Obesity
24,755 Patients Enrolled for Obesity