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Glucagon-like peptide-1 (GLP-1) receptor agonist
A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss (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
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 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
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
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,679 Previous Clinical Trials
3,464,970 Total Patients Enrolled
69 Trials studying Obesity
45,778 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,389 Previous Clinical Trials
427,385 Total Patients Enrolled
51 Trials studying Obesity
24,551 Patients Enrolled for Obesity