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

Tirzepatide for Obesity (SURMOUNT-5 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

Summary

This trial will assess the effectiveness & safety of a new drug for adults with obesity & related conditions, lasting 78 weeks.

Who is the study for?
This trial is for adults with obesity or overweight who have unsuccessfully tried to lose weight through diet and have related health issues like high blood pressure, but not diabetes. Participants should have a BMI of ≥30 kg/m², or ≥27 kg/m² with conditions such as hypertension. Those with recent significant weight changes, severe psychiatric disorders, certain endocrine disorders, pancreatitis, or a family history of specific thyroid cancers cannot join.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of two drugs: Tirzepatide and Semaglutide in individuals without Type 2 Diabetes but who are obese or overweight with related health problems. The trial will run for about 74 weeks to see which drug is better at helping participants lose weight.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea, possible inflammation of the pancreas (pancreatitis), allergic reactions, changes in heart rate or mood swings. Each person's experience can vary.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent Change from Baseline in Body Weight
Secondary outcome measures
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Waist Circumference in Centimeter (cm)
Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg
+5 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%
Gastroenteritis
11%
Vomiting
9%
Abortion induced
9%
Flatulence
7%
Abdominal pain upper
7%
Gingivitis
7%
Amylase increased
7%
Lipase increased
6%
Injection site reaction
6%
Menstruation irregular
6%
Abdominal pain
4%
Hepatic function abnormal
4%
Hyperuricaemia
3%
Uterine polyp
3%
Dizziness
3%
Vaginal infection
1%
Supraventricular tachycardia
1%
Hand fracture
1%
Hiccups
100%
80%
60%
40%
20%
0%
Study treatment Arm
10 mg Tirzepatide
15 mg Tirzepatide
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TirzepatideExperimental Treatment1 Intervention
Participants will receive tirzepatide subcutaneously (SC).
Group II: SemaglutideActive Control1 Intervention
Participants will receive semaglutide SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~5560

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
Common treatments for obesity, such as Tirzepatide (a dual GIP and GLP-1 receptor agonist), Semaglutide, and Liraglutide, work by mimicking incretin hormones that are released after eating. These hormones stimulate insulin release, inhibit glucagon secretion, slow gastric emptying, and reduce appetite. This multi-faceted approach helps patients achieve significant weight loss by improving glucose metabolism and reducing caloric intake, which is essential for managing obesity and its related comorbidities.

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,629 Previous Clinical Trials
3,217,410 Total Patients Enrolled
57 Trials studying Obesity
51,125 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,351 Previous Clinical Trials
415,776 Total Patients Enrolled
40 Trials studying Obesity
30,844 Patients Enrolled for Obesity

Media Library

Semaglutide 2.4 mg (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05822830 — Phase 3
Obesity Research Study Groups: Semaglutide, Tirzepatide
Obesity Clinical Trial 2023: Semaglutide 2.4 mg Highlights & Side Effects. Trial Name: NCT05822830 — Phase 3
Semaglutide 2.4 mg (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05822830 — Phase 3
Obesity Patient Testimony for trial: Trial Name: NCT05822830 — Phase 3
~117 spots leftby Nov 2024